MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 Bardia® Foley Catheter Silicone Coated

Catalog Number	123512A
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Difficult to Remove (1528)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they have not been able to identify specifically which of the sizes is causing problems.Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily.Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage.On several occasions, it became necessary to replace the catheter.On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed.To remove this catheter from the patient.They cut it at the branching point, just behind where the balloon syringe is attached.This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate.
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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.

• Brand Name: Bardia® Foley Catheter Silicone Coated
• Common Device Name: Foley Catheter
• Manufacturer (Section D): C.R. Bard Inc. (Covington) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. Bard Inc. (Covington) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; +1(770)784-6100
• MDR Report Key: 50899363
• Report Number: 1018233-2026-06112
• Device Sequence Number: 18817971
• Product Code: EZC
• UDI-Device Identifier: 00801741095078
• UDI-Public: (01)00801741095078(17)301228(10)MYLQ3401
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 123512A
• Device Lot Number: MYLQ3401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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