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

Catalog Number 0165L18

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

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

Event Date 02/26/2019

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 foley catheter fell out of the patient with a deflated balloon.

Event Description

It was reported that the foley catheter fell out of the patient with a deflated balloon.

Manufacturer Narrative

The reported event was unconfirmed.The evaluation found no leakage observed even when pressure was applied on the sac.The sample underwent a 7 day leak test and no leakage was observed.There was no leakage from the valve.The catheter was dissected and no conditions found that could have contributed to the reported event.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: "warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.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 clip and squeeze reservoir to inflate with stated ml of sterile water.".

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: BIOCATHFOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8508807
• MDR Text Key: 141920169
• Report Number: 1018233-2019-01921
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: 0165L18
• Device Lot Number: 8GN0067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1