MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 8 FRENCH NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETERS

Catalog Number NOD8LPT

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review is being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model nod8lpt drainage catheter allegedly experienced fracture and leak.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The weight of the (b)(6) female patient was not provided.

Manufacturer Narrative

As the lot number for the device was provided, a lot history review is being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model nod8lpt drainage catheter allegedly experienced fracture and leak.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The weight of the 68 year old female patient was not provided.

• Brand Name: 8 FRENCH NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETERS
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10289561
• MDR Text Key: 199276131
• Report Number: 3006260740-2020-02534
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741037092
• UDI-Public: (01)00801741037092
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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
• Device Operator: No Information
• Device Catalogue Number: NOD8LPT
• Device Lot Number: GFCX4140
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1