Implicated product is 3.
0 fr.
Single lumen picc with full procedural tray.
Product received for eval is 25.
0 inch long 3.
0 fr.
Single lumen catheter with flushing stylet in place.
Catheter is threaded over flushing stylet sent so it is flush with base of luer connector.
Lot history review reveals no related mfg issues and no other complaints for this lot.
Patency of catheter is demonstrated by flushing and aspirating water through catheter with 12cc syringe.
Small leak is noted during flushing 0.
9 inches proximal to catheter's distal tip.
Aspiration with only valve submerged below water level results in drawing air into syringe.
Microscopic examination (32c -63x) of catheter outer diameter at location of leak shows small, somewhat elliptical hole.
Distal tip of stylet is seen within lumen extending beyond this hole approximately 0.
1 inch.
Hole has irregular edges with steep, rough walls that indicate blunt trauma (as opposed to sharp instrumentation).
Stylet is withdrawn without difficulty and catheter outer diameter immediately opposite hole is cut open using point of 25ga.
Needle.
Magnified views of inner diameter show hole to be circular with an irregular edge & dull, rough walls that taper to ellipse at outer diameter.
Circular surface impression and a short superficial longitudinal nick in inner diameter are located in same general area of hole.
Circular surface impression may have been caused by manipulation of stylet tip and nick may have occurred during catheter dissection during this examination.
Microscopic views of stylet show distal tip to have rounded, blunt end with no sharp points or edges.
Size comparison of stylet's distal tip with hole in catheter outer diameter show hole to be condiderably smaller.
However, hole in catheter inner diameter is roughly same size as stylet's distal itp.
This implies hole in inner diameter is entry hole caused by stylet.
Stretching of silicone as stylet passed through wall caused tapering hole walls and elliptical exit hole in outer diameter.
Complaint of flushing stylet piercing picc wall is confirmed.
It should be recorded as user-related.
Location of stylet's distal tip when complaint sample was recieved along with its size and shape correspond with entry hole in tubing inner diameter.
Blunt end of stylet tip and natural stretching of silicone material as tension is applied accounts for rough walls and irregular edges and smaller exit hole.
Complaint file does not provide info regarding any complications or difficulties encountered during placement procedure.
However, complaint sample was reveived with proximal end of catheter tubing butted against stylet's luer adapter; product is normally shipped with catheter only partially covering stent.
This suggests tubing had been manipulated over stylet by user.
Damage may have occurred during tubing manipulation.
Product instructions for use directs user to flush saline through stylet luer to aid in placement and/opr raising pt's arm to shoulder level.
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