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

Catalog Number 0165L14

Device Problems Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 tubing was shorter than normal and pulled the catheter down.

Manufacturer Narrative

This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.The device was not returned for evaluation.However, the potential root cause for this failure mode could be wrong product size selected/speed controller faulty/mix product (catheter).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clips and squeeze reservoir to inflate with stated ml of sterile water.".

Event Description

It was reported that the tubing was shorter than normal and pulled the catheter down.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: BIOCATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8500930
• MDR Text Key: 141736103
• Report Number: 1018233-2019-01814
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 0165L14
• Device Lot Number: NGCS4335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1