MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SV, 3FR S/L TPS, BASIC; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	1173118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2017
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 reax0256 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported via medwatch that during a blood draw, blood was detected under the picc dressing.A pin hole was found located between the catheter and the hub, this was a source of a blood leak.
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 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, but the exact cause could not be determined.One 3fr s/l powerpicc sv was received with evidence of use.A tacky residue, which most likely remained from the dressing, was observed on the external surface of the extension leg, molded wing, and the s/l tubing between the wing and the 1cm depth mark.Functional testing revealed a leak at the distal end of the molded wing.The surface of the tubing around the hole was rough and granular.It appears that the tubing began to tear just inside the distal end of the molded wing.The extent of damage was noted to be greater toward the external surface of the catheter, which indicates that the damage did not initiate from within the lumen.The hole could be attributable to chemical exposure and/or stress applied from kinking or flexing the tubing close to where it was constrained by the bifurcation; however, the exact cause and all contributing factors could not be determined.The instructions for use (ifu) states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿.
Event or Problem Description
It was reported via medwatch that during a blood draw, blood was detected under the picc dressing.A pin hole was found located between the catheter and the hub, this was a source of a blood leak.

• Brand Name: POWERPICC SV, 3FR S/L TPS, BASIC
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6445835
• Report Number: 3006260740-2017-00330
• Device Sequence Number: 621733
• Product Code: LJS
• UDI-Device Identifier: 00801741086892
• UDI-Public: (01)00801741086892(17)200228(10)REAX0256
• 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: Manufacturer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017
• Report Date (Section F): 02/01/2017

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 Expiration Date: 02/28/2020
• Device Catalogue Number: 1173118
• Device Lot Number: REAX0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 5
• Date Report Sent to FDA: 02/01/2017