MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8 FRENCH NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL; CHRONIC CATHETER

Catalog Number	NNU8PT
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, the lot number was provided for the malfunction; therefore, a lot history review has been performed.The devices was not returned to bd.Two photo were provided and reviewed.The first photo shows the end of a navarre catheter, with a red marking on the image emphasizing a visible crease on the catheter.The second photo shows the label the lot number and catalog number match the tw description.In light of the lack of a returned sample and the inability to confirm that the line on the catheter in fact leaks.Based upon the available information, the definitive root cause for this event is unknown.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model nnu8pt.Chronic catheter allegedly experience fluid break.This report was received from a single source.This event did not involve patient with no reported patient contact.Age, weight, and gender were not provided for the patient.

• Brand Name: 8 FRENCH NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9593300
• Report Number: 3006260740-2020-00108
• Device Sequence Number: 16897216
• Product Code: GBX
• UDI-Device Identifier: 00801741037016
• UDI-Public: (01)00801741037016
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: No Information
• Device Catalogue Number: NNU8PT
• Device Lot Number: GFDS2503
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1