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

Catalog Number 0165L14

Device Problem Gel Leak (1267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported that the customer had a problem with the new foley indwelling catheterization sets when they were catheterizing the patient for an emergency cesarean section.There was a small opening in the foley catheter sachet and no second sachet, so there was an increased risk of aseptic faults.It was stated that the catheter was very rigid and the customer had difficulty in mounting the catheter.After checking, the catheter was found to be incorrectly placed and the user replaced it with old catheter.It was stated that the another midwife had the same problem last week.Per follow up information received via ibc on 24mar2022, it was stated that there was no information regarding the lot number for the catheter with which the midwife had mounting problem.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event was unconfirmed.No root cause could be found because the reported event was unconfirmed.There was no water sachet shipped along with the package.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not required as the reported event was unconfirmed.The information provided by bd represents all 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.

Event Description

It was reported that the customer had a problem with the new foley indwelling catheterization sets when they were catheterizing the patient for an emergency cesarean section.There was a small opening in the foley catheter sachet and no second sachet, so there was an increased risk of aseptic faults.It was stated that the catheter was very rigid and the customer had difficulty in mounting the catheter.After checking, the catheter was found to be incorrectly placed and the user replaced it with old catheter.It was stated that the another midwife had the same problem last week.Per follow up information received via ibc on (b)(6) 2022, it was stated that there was no information regarding the lot number for the catheter with which the midwife had mounting problem.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14918989
• MDR Text Key: 302857917
• Report Number: 1018233-2022-05177
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L14
• Device Lot Number: NGFY2728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other