Findings: complaint of a crack in line is confirmed.
User has facilitated in repairing venous luer.
Two samples have been returned for eval sample "a" 23cm straight d/l catheter and sample "b" 19cm straight d/l catheter.
Sample "a" has been returned in two sections.
Proximal section contains arterial and repaired venous luer, extension legs, bifurcation site and the cuff.
A break in the catheter is observed 1.
3" distal to the cuff.
A blood residue is seen imbedded in the cuff.
Also returned is a loose venous luer.
No mechanical damage is observed with venous and arterial luers.
A dark yellow discoloration is found on extension legs and bifurcation site, becoming lighter and dissipating just distal to the distal end of bifurcation site.
This yellow discoloration is most likely from antiseptics used to clean the catheter.
Identification flow markings on venous and arterial extension legs are unremarkable.
Three blue monofilament sutures are tied to the catheter, two are found on suture orientation holes found on delta wing, third suture is tied just distal to the bifurcation site.
A heavy blood residue is found throughout the catheter.
Sample "b" has been returned complete and measures 13.
9" in length.
A blood residue is found on sample.
A chr review is not possible, as no mfg lot number has been provided by the complainant.
Calibrated instruments used in eval of this complaint- steel ruler cm-212.
Microscopic exam (10x-40x) of venous luer shows a reasonably longitudinal crack that begins at second screw thread and proceeds distally and then dissipates perpendicularly to axis of connector.
Viewing crack from inside orifice of venous luer the crack appears limited between inner diameter and outer diameter walls.
Longitudinal opening on od of luer is larger than crack on id wall.
Smaller fissures and stress marks on od are found around break site.
Insertion of male slip connector of a 12cc syringe causes crack to open wider.
Microscopic exam (1ox-40x) of arterial luer shows a small longitudinal crack that also begins on second screw thread and proceeds distally.
This crack is not as large as venous luer crack and doesn't change direction perpendicularly.
However, insertion of male slip connector of a 12cc syringe causes crack to open wider.
Magnified exam of extension legs confirms discoloration of both as well as bifurcation site.
Comparison of extension legs of complaint sample with a non-complaint device reveals a dramatic difference in leg material clarity.
It is not known what type of cleaning agent has been exposed to catheter, discolored tubing and tactual weakness suggests exposure to a harsh catheter maintenance preparation.
Microscopic exam (15x) of break site that is 1.
3" distal to cuff is jagged and irregular.
A cross section view of break site shows approx half veneer is smooth, glossy and striated.
Edge is straight and well defined with walls that are relatively flat and smooth.
These traits indicate catheter was cut with a sharp instrument such as a scalpel or knife.
Other half is slightly granular and dull.
This is indicative of a tensile break.
Break in catheter in conjunction with cut in tubing probably occurred during removal of catheter.
Broken ends exhibit a match when mated together.
Sample "b" was observed under 20x magnification and is unremarkable.
For sample "a" a tactual exam of the complaint sample shows occlusion clamp.
Impressions in both extension legs.
Sample "b" is unremarkable.
Proximal section (sample "a") was tested for patency.
Patency testing of venous lumen is accomplished by flushing with a 12cc syringe filled with water.
This procedure was repeated to arterial lumen with same results.
Next, catheter was then manually occluded with a flat edge clamp and arterial and venous lumens were hydraulically pressurized sequentially.
No leaks were observed.
Distal section was accessed by using a blunt connector from bas lab.
Distal section infused with no difficulty.
Distal end of distal section was manually occluded with a flat edge clamp.
No leaks were observed during pressurization.
Next, loose venous luer was attached to 12cc syringe filled with water.
Distal end of connector was occluded by examiners thumb.
Connector was hydraulically pressurized.
A small seeping leak was observed coming from venous connector.
Gross exam of luer shows male slip connector of syringe causes crack edges to spread.
Connecting syringe to connector does not hold crack edges together and restrict or prevent leak.
This was repeated to arterial luer except extension leg clamp was closed to pressurize connector.
A slow weeping leak was observed.
It should be noted during initial pressurization of proximal section leak in arterial luer was not observed.
Again syringe caused crack to spread.
Connecting syringe to venous and arterial connectors does not hold crack edges together and restrict or prevent leaks.
Sample "b" infused with no difficulty.
During pressurization no leaks were observed with arterial or venous luers.
Complaint of a crack in line is confirmed.
User has facilitated in repairing venous luer.
Microscopically, cracks found in venous and arterial connectors have well-defined edges that close tightly against each other when relaxed.
Attaching a male slip connector of a 12cc syringe causes fissures on both arterial and venous luers to spread wider.
Microscopic exam of break site that is found distal to cuff reveals a partial tear in conjunction with partial cut.
This damage may have occurred during explantation.
Discolored extension legs and bifurcation site suggests tubing degradation secondary to exposure of tubing to a harsh skin prep and catheter cleaning solutions.
Although it is not known what type of care and maintenance protocol that was performed on complaint sample the product ifu warns user, "acetone & peg-containing ointments can cause failure of device and should not be used with polyurethane catheters.
" sample "b" is unremarkable and functioned as designed.
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