MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV, 4FR D/L TPS, BASIC; 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	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebs2879 showed no other similar product complaint(s) from this lot number.Device, not yet returned.
Event or Problem Description
Per medwatch it was reported that the catheter was leaking at the base of the catheter.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed, and will be considered use related.One 4 fr d/l powerpicc sv was returned for investigation.The returned sample revealed evidence of use.The printing was partially worn from the extension legs.Adhesive residue from what was most likely a dressing was observed on the bifurcation and d/l tubing between the bifurcation and 2cm depth mark.The catheter extended to the 25cm depth mark, where the catheter had been trimmed.A semi-circumferential split was observed in the d/l catheter just distal to the molded bifurcation.The split was located on the inside of a kink in the tubing.A microscopic examination of the split revealed a rough and granular edge and adjoining surfaces.A tactual investigation revealed that the tubing had the tendency to kink across the split that was found in the tubing.The split found in the catheter indicates that the tubing was placed in a location that was vulnerable to kinking.The repeated kinking of the catheter most likely caused the tubing to crease, which lead to splitting of the tubing material.The product ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ no damage related to the manufacturing process was noted on the returned complaint sample.A lot history review (lhr) of rebs2879 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
Per medwatch it was reported that the catheter was leaking at the base of the catheter.No patient injury was reported.

• Brand Name: POWERPICC SV, 4FR D/L TPS, BASIC
• 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: 7013740
• Report Number: 3006260740-2017-01984
• Device Sequence Number: 16462509
• Product Code: LJS
• UDI-Device Identifier: 00801741086915
• UDI-Public: (01)00801741086915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018
• Report Date (Section F): 09/28/2017

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: 1274118
• Device Lot Number: REBS2879
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/28/2017