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Adverse Event Report

BARD ACCESS SYSTEMS RADD PICC LONG TERM INTRAVASCULAR CATHETER   back to search results
Device Problems Device breakage; Implant, removal of
Event Date 02/01/2001
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Intro wire, frayed or broke in patient. No other information given.

 
Manufacturer Narrative

This complaint is confirmed and will be recorded as user related. As evidenced by the sample the stylet wire has been damaged through misuse. The product implicated is a picc catheter. Returned for evaluation is a damaged stylet wire. No blood residue is seen on the stylet wire. A chr review is not possible, as no manufacturing lot number has been provided by the complainant. According to the notes contained in this file the wire frayed or broke in the patient. No other information was given. The stylet wire was observed under 10x magnification. The coils of the stylet wire have deviated and are no longer concentric with the rest of the coils. The center wire has broken from its tip weld at the distal end of the wire and is on a slight angle. The tip is smooth and reflective and suggests the user has cut the wire. The center wire is seen protruding through the outer coils. The weld tip is missing from the distal end of the wire and its location is unknown. The stylet wire is also stretched and elongated. This may have occurred during retraction or manipulation of the stylet wire. The ifu states, "attach a syringe with heparinized saline solution or sterile water to the luer lock fitting of the flush through stylet hub. Inject enough solution to wet the stylet surface entirely. This will activate the hydrophilic coating, making the stylet surface very lubricious. Remove the stylet from its holder and insert it into the catheter if the catheter has been trimmed, only advance the stylet to the distal end of the catheter. If the surface of the stylet becomes dry after removal from the holder, wetting with additional heparinized saline or sterile water will renew the hydrophilic effect". This complaint is confirmed and will be recorded as user related. As evidenced by the sample the stylet wire has been damaged through misuse. It appears that during placement the user may have inadvertently cut the stylet wire during placement. This appears to be a user technique issue. The ifu gives written and illustrated instructions on catheter placement.

 
Search Alerts/Recalls

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Brand NameRADD PICC
Type of DeviceLONG TERM INTRAVASCULAR CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer (Section D)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer Contact
bryan ball, mgr.
5425 west amelia earhart dr.
salt lake city , UT 84116
(801) 595 -0700
Device Event Key323743
MDR Report Key334399
Event Key314729
Report Number1720496-2001-00309
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2001
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2001
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/01/2001
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer04/11/2001
Date Manufacturer Received04/11/2001
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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