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

Catalog Number 0165L14

Device Problems Burst Container or Vessel (1074); Deflation Problem (1149); Device Dislodged or Dislocated (2923)

Patient Problems Blood Loss (2597); Patient Problem/Medical Problem (2688)

Event Date 06/18/2020

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 indwelling catheter fell out from the patient with deflated balloon and also stated that patient experienced bleeding.It was unknown whether the balloon of the catheter burst.However, another catheter was reinserted to patient.Per additional information received via email on 22 jun 2020 from ibc representative, the balloon was noted to be burst after it fell out, there were no reports of missing pieces.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.The sample has been evaluated and noted that the sac with the irregular burst was observed.No pieces of sac were missing.However, the exact cause of how and when the problem was occurred could not be determined and could not be classified as a manufacturing related.A potential root cause for this failure mode could be due to a user related (example: contact with sharp objects/ exposed to petrolatum based products/ mechanical failure/operator error).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.For urological use only.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." h11:section a through f - the information provided by bd represents all of 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 indwelling catheter fell out from the patient with a deflated balloon and also stated that the patient experienced bleeding.It was unknown whether the catheter balloon burst.However, another catheter was reinserted to the patient.Per additional information received via email on (b)(6) 2020 from the ibc representative, the balloon burst was noted after the catheter fell out, there were no reports of missing pieces.No medical intervention was reported.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10259615
• MDR Text Key: 199059418
• Report Number: 1018233-2020-04478
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741159985
• UDI-Public: (01)00801741159985
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 9MN070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1