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

Catalog Number 0168L16

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Event Description

It was reported that customer had issues with the foley catheter kit standard one and the coude.They were aware that best practice stated to not test balloons, but this was concerning if the balloons would not deflate when going to remove from a patient.When staff tested the balloon, the fluid did not automatically come back in the syringe, so staff thought something was wrong.Brooke stated they went and got another catheter kit and they played with the one they had already opened.Once they detached the syringe and reattached, then the fluid for the balloon came back out.This was a few weekends ago.This past weekend kathy did not detach and reattach the syringe when testing the balloon, but the next kit they got out to place for the patient the balloon deflated without detaching and reattaching the syringe.Customer saved the foley they used.It was the coude kit.Kathy stated they tried pulling the fluid back out of the balloon and it would not come out of the first kit they opened.When customer was playing with it, they detached and reattached syringe and the fluid came back out of balloon automatically.They did not know if there was an issue with the product, but it appeared some balloons are deflating like they always have with the syringe attached.Some catheter kits they had to detach and reattach the syringe to trigger the balloon to deflate.These are the 2 numbers found on the coude catheter held.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

Upon further review, bd has determined that this initial mdr was reported in error.H11: section a through f - the information provided by bd represents all 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 customer had issues with the foley catheter kit standard one and the coude.They were aware that best practice stated to not test balloons, but this was concerning if the balloons would not deflate when going to remove from a patient.When staff tested the balloon, the fluid did not automatically come back in the syringe, so staff thought something was wrong.Brooke stated they went and got another catheter kit and they played with the one they had already opened.Once they detached the syringe and reattached, then the fluid for the balloon came back out.This was a few weekends ago.This past weekend kathy did not detach and reattach the syringe when testing the balloon, but the next kit they got out to place for the patient the balloon deflated without detaching and reattaching the syringe.Customer saved the foley they used.It was the coude kit.Kathy stated they tried pulling the fluid back out of the balloon and it would not come out of the first kit they opened.When customer was playing with it, they detached and reattached syringe and the fluid came back out of balloon automatically.They did not know if there was an issue with the product, but it appeared some balloons are deflating like they always have with the syringe attached.Some catheter kits they had to detach and reattach the syringe to trigger the balloon to deflate.These are the 2 numbers found on the coude catheter held.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18335841
• MDR Text Key: 331058595
• Report Number: 1018233-2023-08969
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017827
• UDI-Public: (01)00801741017827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0168L16
• Device Lot Number: NGHV3400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other