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

Catalog Number	365716
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon was not deflating.Per follow up via email on 07feb2025.It was reported that the product catalog number was 0165l20 and the lot number was ngju2545.The patient was identified as a female.The catheter broke inside the patient, but the catheter came out of the patient.There was no harm, but catheter was replaced.The patient came into the clinic and stated that the catheter had come out due to the balloon popping.The customer was at home when it happened and then went to the emergency department to had it replaced.The patient stated this was the second time it had happened and would not allow staff to use the same kind of catheter again.Patient brought the catheter into the clinic.Currently staff had it in materials ready to go out to the manufacturer.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample condition.It was unknown whether the product had caused the reported failure.Sample was evaluated and observed inflation eye are meet internal specification.However, due to poor sample condition the complete investigation could not be performed, and this complaint is classified as inconclusive-poor sample condition.A potential root cause for this failure could be thin rubberize wall (example: causing collapse/ pinched inflation lumen under the balloon) or user related mishandling during used.No actions can be taken at this time since a root cause was not identified.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: do not use ointments or lubricants having a petrolatum base.They will damage latex and may burst balloon.Caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Balloon burst can lead to premature deflation."visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities: 3cc balloon: use 5cc sterile water, 5cc balloon: use 10cc sterile water, 15cc balloon: use 20cc sterile water, 20cc balloon: use 25cc sterile water, 30cc balloon: use 35cc sterile water, 40cc balloon: use 45cc sterile water, 75cc balloon: use 50cc sterile water, do not exceeded recommended capacities." 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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact and adequately trained professional for assistance, as directed by hospital protocol.Udi format updated with available product information per gudid.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 or Problem Description
It was reported that the foley catheter balloon was not deflating.Per follow up via email on 07feb2025.It was reported that the product catalog number was 0165l20 and the lot number was ngju2545.The patient was identified as a female.The catheter broke inside the patient, but the catheter came out of the patient.There was no harm, but catheter was replaced.The patient came into the clinic and stated that the catheter had come out due to the balloon popping.The customer was at home when it happened and then went to the emergency department to had it replaced.The patient stated this was the second time it had happened and would not allow staff to use the same kind of catheter again.Patient brought the catheter into the clinic.Currently staff had it in materials ready to go out to the manufacturer.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21343310
• Report Number: 1018233-2025-00723
• Device Sequence Number: 12721597
• Product Code: EZC
• UDI-Device Identifier: 00801741077746
• UDI-Public: (01)00801741077746(11)240402(17)281228(10)MYJP0991
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 365716
• Device Lot Number: MYJP0991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown