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

Model Number 165812

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 04/30/2021

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 it was unable to pull the foley catheter after withdrawing the full amount of water in the balloon.It was stated that the research nurse attempted with difficulty, so pushed back in approximately 10cm.Lidocaine gel was applied and md attempted to remove the catheter with no success.Stated that there was a resistance at approximately 4 cm of the catheter.Eventually the catheter was removed by an urologist and found that small ring at 4cm mark was raised which created the resistance while removing the catheter.Per additional information via email from ibc on 14may2021, it was stated that the patient experienced pain while removing the catheter and there was no injury reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "balloon masking the inflation eye due to incorrect location ".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, 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.Visually inspect the product for any imperfections or surface deterioration prior to use." 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.H3 other text : the device was not returned.

Event Description

It was reported that it was unable to pull the foley catheter after withdrawing the full amount of water in the balloon.It was stated that the research nurse attempted with difficulty, so pushed back in approximately 10cm.Lidocaine gel was applied and md attempted to remove the catheter with no success.Stated that there was a resistance at approximately 4 cm of the catheter.Eventually the catheter was removed by an urologist and found that small ring at 4cm mark was raised which created the resistance while removing the catheter.Per additional information via email from ibc on (b)(6) 2021, it was stated that the patient experienced pain while removing the catheter and there was no injury reported.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11899118
• MDR Text Key: 253212936
• Report Number: 1018233-2021-03081
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029738
• UDI-Public: (01)00801741029738
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: 165812
• Device Catalogue Number: 165812
• Device Lot Number: NGDQ0389
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other