MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5F DL POWERPICC SOLO FT, TLS, MAX BARRIER; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	9295108FD
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/09/2017
Type of Reportable Event	Serious Injury
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 for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.
Event or Problem Description
It was reported via medwatch that while the introducer was being placed at the insertion site and over the guidewire, the nurse attempted to insert the introducer twice.On the third attempt and the second nick to widen the insertion site, she realized the guidewire had migrated inside the patient.She could feel the very end of the guidewire and stopped the procedure.This device does not include any type of guidewire clip identification that could be placed at the end of the wire to assist with monitoring the status of the guidewire while attempting to place the introducer or preventing it from migrating during this process.

• Brand Name: 5F DL POWERPICC SOLO FT, TLS, MAX BARRIER
• 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: 6494711
• Report Number: 3006260740-2017-00420
• Device Sequence Number: 16476637
• Product Code: LJS
• UDI-Device Identifier: 00801741035784
• UDI-Public: (01)00801741035784
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/14/2017
• Report Date (Section F): 03/08/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9295108FD
• Device Lot Number: REZJ02011 (INVALID)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• 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
• Date Report Sent to FDA: 03/08/2017