MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be 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 instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 11/2022.

Event Description

It was reported that sometime post drainage catheter placement procedure, the joint allegedly cracked and fluid leaked.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive for the reported fracture and fluid leak.A definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 11/2022).H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

Event Description

It was reported that during drainage catheter placement procedure, the catheter hub allegedly cracked and fluid leaked.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: 8 FRENCH NAVARRE OPTI-DRAIN MULTI-USE DRAINAGE CATHETERS
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11383943
• MDR Text Key: 234817152
• Report Number: 3006260740-2021-00501
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/08/2021

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: Health Professional
• Device Catalogue Number: NOD8LPT
• Device Lot Number: GFDX2625
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 05/08/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other