MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a kink in the stylet was confirmed, but the exact cause could not be determined from the four photographs that were provided for investigation.The photos showed one 3cg stylet that had been removed from the picc.The picc was not observed in the photos.The t-lock extension set remained attached to the stylet.A kink was observed in the stainless steel core wire between the t-lock extension set and the polyimide tubing.A kink was also observed in the polyimide tubing.The kink in the polyimide tubing appeared to be located proximal to the magnets.The stylet appeared complete and no part of the stylet appeared to be broken.Since the stylet was kinked, the complaint was confirmed; however the cause of the stylet could not be determined.Based on the condition of the stylet, it is possible that the stylet was damaged during use.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 recq0261 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recq0261) have been reported from the same facility.
Event or Problem Description
It was reported that the stylet was kinked upon removal after successful picc placement.

• Brand Name: POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/GUARDIVA & PROBE COVER
• 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: 8142196
• Report Number: 3006260740-2018-03502
• Device Sequence Number: 1910163
• Product Code: LJS
• UDI-Device Identifier: 00801741154904
• UDI-Public: (01)00801741154904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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: 08/30/2019
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD2
• Device Lot Number: RECQ0261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 65