MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER CREEVY MODEL; IRRIGATION CATHETER

Model Number 01267522

Device Problems Gas/Air Leak (2946); No Apparent Adverse Event (3189)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the foley catheter balloon was suspected of having air even before opening it for use.It was noted that a new foley had been unpacked for use.

Event Description

It was reported that the foley catheter balloon suspected of having air even before opening it for use.It was noted that a new foley had been unpacked for use.

Manufacturer Narrative

Per the investigations findings, bard.Bd has determined that this event is not reportable as the catheter was not a defective.The catheters are intentionally inflated with air to prevent the balloon from sticking to shaft.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER CREEVY MODEL
• Type of Device: IRRIGATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10157538
• MDR Text Key: 195896426
• Report Number: 1018233-2020-03869
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018817
• UDI-Public: (01)00801741018817
• Combination Product (y/n): N
• PMA/PMN Number: K910195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 01267522
• Device Catalogue Number: 01267522
• Device Lot Number: NGDQ3831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1