MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT; CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redp0694 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed in the arm of patient and the external lumen was broken in two pieces when doing the dressing change.No reported patient injury.
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 that the extension leg was transected in two pieces was confirmed and the cause of the damage appeared to be associated with use of the device.One 5fr triple-lumen (t/l) powerpicc solo was returned for investigation.Evidence of use was observed on the catheter.The extension leg with the white/blue connector had been transected in two pieces.The adjoining surfaces of the extension leg tubing exhibited a glossy and striated veneer that was consistent with a cut made with a sharp instrument.The transection in the tubing was located 1.7cm from the proximal end of the trifurcation.It was reported that the extension leg was damaged during a dressing change.It appeared that the extension leg tubing was inadvertently cut with a sharp instrument.Due to the information provided in the reported event and the characteristics observed on the returned sample, the complaint was confirmed and the cause was determined to be related to use of the device.A lot history review (lhr) of redp0694 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was placed in the arm of patient and the external lumen was broken in two pieces when doing the dressing change.No reported patient injury.

• Brand Name: POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY AND SHERLOCK 3CG TIP POSIT
• 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: 9179873
• Report Number: 3006260740-2019-02969
• Device Sequence Number: 2774773
• Product Code: LJS
• UDI-Device Identifier: 00801741112744
• UDI-Public: (01)00801741112744
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2019

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: S1395108
• Device Lot Number: REDP0694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1