MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET; 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	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed and appears to be related to the use of the device.Two photo samples of a 5 fr tl powerpicc provena catheter were returned for investigation.The first photo sample shows the trifurcation hub section of the catheter.Use residue is present throughout the catheter.The power injectable extension leg is shown to be detached from the trifurcation hub.The distal end of the power injectable extension leg appears to be uneven which indicates the tubing likely fractured.The second photo sample shows the product insertion date and a label sticker with ref: s1385108 and lot: recw0940.The event description states, "patient was alcohol detox and pulled on the center lumen of picc with intention of pulling the line out." based on the photo sample provided and description of the reported event, the complaint is confirmed to be related to the use of the device.A lot history review (lhr) of recw0940 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that patient was in alcohol detox and pulled on the center lumen of picc with intention of pulling the line out.It was stated the patient successfully pulled off the center lumen but did not dislodge the dressing or statlock.

• Brand Name: POWERPICC PROVENA 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: 8782724
• Report Number: 3006260740-2019-01923
• Device Sequence Number: 2359963
• Product Code: LJS
• UDI-Device Identifier: 00801741112713
• UDI-Public: (01)00801741112713
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• 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): 07/11/2019

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 Model Number: N/A
• Device Catalogue Number: S1385108
• Device Lot Number: RECW0940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1