MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; 2 WAY FOLEY BIOCATHETER

Catalog Number 0165L16

Device Problems Burst Container or Vessel (1074); Material Rupture (1546); Component Missing (2306)

Patient Problems Hemorrhage/Bleeding (1888); Urinary Retention (2119); Hematuria (2558); Patient Problem/Medical Problem (2688)

Event Date 09/26/2018

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 patient experienced a balloon burst on several different occasions noted below: (b)(6) 2018, (b)(6) 2019.Per additional information provided from the ibc via email (b)(6) 2019; the patient suffers from an enlarged prostate with urinary retention.The catheter was placed transurethrally using the syringe supplied in the tray.During each catheter change, the patient experienced bleeding.Per additional information from the ibc via email (b)(6) 2019; it is unknown if the balloon was missing any pieces.

Manufacturer Narrative

The device was not returned for evaluation.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 patient experienced a balloon burst on several different occasions noted below: (b)(6) 2018, (b)(6)2019.Per additional information provided from the ibc via email 21jan2019; the patient suffers from an enlarged prostate with urinary retention.The catheter was placed transurethrally using the syringe supplied in the tray.During each catheter change, the patient experienced bleeding.Per additional information from the ibc via email 22jan2019; it is unknown if the balloon was missing any pieces.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: 2 WAY FOLEY BIOCATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8282955
• MDR Text Key: 134310118
• Report Number: 1018233-2019-00430
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 0165L16
• Device Lot Number: NGCV0973
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1