MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR DUAL LUMEN POWERPICC SV; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
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 rebz0681 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported, "resulted in need for emergent overwire exchanged of picc with patient drips on hold x 30 minutes." no other information was provided.
Event or Problem Description
It was reported, "resulted in need for emergent overwire exchanged of picc with patient drips on hold x 30 minutes." no other information was provided.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter is confirmed; however, the exact cause is unknown.One 4 fr dual lumen powerpicc sv was returned for evaluation.An initial visual observation showed use residue on the returned sample.The ink on the hubs and extension legs was observed to be worn and faded.Each lumen was flushed with a 12 ml syringe of water and a leak was observed in the catheter just distal to the molded joint when the red lumen was flushed.When manipulating the catheter near the distal end of the molded joint, it was found that the catheter readily kinked at the location of the split with the split at one of the corners of the kink.A microscopic observation revealed a longitudinal split just distal to the molded joint.The edges of the split were observed to be straight and the fracture surface was observed to be flat and mostly granular with the inner edges of the split observed to be slightly uneven.A shallow circumferential indentation was observed on the side of the catheter opposite the split.While the returned catheter does display some features characteristic of fatigue damage caused by prolonged and/or cyclic kinking of the catheter tubing, not enough evidence of this failure mode was found on the returned sample to confirm this failure mode; therefore, the root cause is unknown.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.

• Brand Name: 4 FR DUAL LUMEN POWERPICC SV
• 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: 9257052
• Report Number: 3006260740-2019-03395
• Device Sequence Number: 1879548
• Product Code: LJS
• UDI-Device Identifier: 00801741130045
• UDI-Public: (01)00801741130045
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: UNKNOWN
• Device Lot Number: REBZ_0681 (INCORRECT)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1