MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO PROVENA CATHETER, 5F TL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend 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 ruptured picc was inconclusive because of the nature of the returned sample.The product returned for evaluation was two photographs depicting a 5fr t/l powerpicc solo provena.The depicted portion of the device included the molded joint and the extension tubes.A portion of catheter shaft was visible in the first photograph.Fluid residue was observed within the extension tubes and the markings were partially worn.Neither leakage nor extension tubing damage were clearly discernible during inspection of the submitted photographs; however, the depicted device could not be thoroughly examined or functionally tested.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of reds4306 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that picc ruptured near the external grey lumen near the hub during flushing.

• Brand Name: POWERPICC SOLO PROVENA CATHETER, 5F TL, 3CG
• 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: 9627039
• Report Number: 3006260740-2020-00286
• Device Sequence Number: 418118
• Product Code: LJS
• UDI-Device Identifier: 00801741161162
• UDI-Public: (01)00801741161162
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2020

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 Model Number: N/A
• Device Catalogue Number: CK000291C
• Device Lot Number: REDS4306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1