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

Catalog Number 01267524-BARD

Device Problem Difficult to Remove (1528)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the two of the catheters were not able to deflate fully.

Manufacturer Narrative

The reported event was confirmed manufacturing related.2 samples were confirmed to exhibit the reported failure.A potential root cause for this failure could be "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required as the reported event is confirmed manufacturing related.The actual/suspected device was inspected.

Event Description

It was reported that two of the catheters were not able to deflate fully.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER CREEVY MODEL
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10747965
• MDR Text Key: 213445217
• Report Number: 1018233-2020-20507
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

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: 01267524-BARD
• Device Lot Number: MYDR2702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: 10/04/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other