MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a kink in the 3cg stylet was confirmed, but the exact cause could not be determined from the returned sample.One 3cg stylet was returned for investigation.The picc was not returned for investigation.The stainless steel wire was kinked at the proximal end of the septum on the t-lock extension set.The wire was also kinked at the distal end of the funnel that was attached to the t-lock extension set.The polyimide tubing was kinked 5.8cm from the distal tip of the stylet.A slight bend was observed in the polyimide tubing 1cm proximal to the kink.The stainless steel wire was bent 21.3cm, 28.4cm, and 35.9cm proximal to the kink in the polyimide tubing.A microscopic examination revealed that the kink in the polyimide tubing was located at the proximal end of the magnets.A tactual investigation revealed that the polyimide tubing was intact.Due to the condition of the stylet, it is possible that the stylet was damaged during insertion or from handling prior to insertion; however, the exact cause of the damage and could not be determined.The ifu for the 3cg stylet states, ¿ensure that the stylet tip does not extend beyond the trimmed end of the catheter.Extension of the stylet tip beyond the catheter end, combined with kinking and excessive forces, may result in vessel damage, stylet damage, difficult removal, stylet tip separation, potential embolism and risk of patient injury.¿ a lot history review (lhr) of redx4954 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported " late last week we had yet another bent wire in a picc kit.This time it was noticed it after insertion.She said the insertion went very smoothly and there was no resistance when she removed the wire.The wire is again bent in almost the exact same spot as the other 2 were.I have again saved the wire for you." on (b)(6) 2020 - returned sample shows the wire is kinked.

• Brand Name: POWERPICC SOLO FT CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9957785
• Report Number: 3006260740-2020-01266
• Device Sequence Number: 2827715
• Product Code: LJS
• UDI-Device Identifier: 00801741034626
• UDI-Public: (01)00801741034626
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 1295108FD
• Device Lot Number: REDX4954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1