MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (12.5CM); CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of redp1857 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported via received medwatch that the "doctor was placing bd cath on patient.Upon removal of the guide wire the inner part of wire was removed while the outer coil peeled away apparently broke off inside the patient.This was visualized on post line chest x-ray.The original catheter initially gave blood return but after placement there was no blood return.This catheter was removed and another was inserted without issue.Repeat x-ray still showed wire so a ct scan of chest was done and patient was scheduled to go to the cath lab for removal of wire".

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (12.5CM)
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9756957
• Report Number: 3006260740-2020-00625
• Device Sequence Number: 16810272
• Product Code: NIE
• UDI-Device Identifier: 00801741041938
• UDI-Public: (01)00801741041938
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/26/2020
• Report Date (Section F): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5613120
• Device Lot Number: REDP1857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/20/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 129
• Date Report Sent to FDA: 01/28/2020