MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® URINE METER WITH BAG; DRAIN BAG

Catalog Number	153204
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name: (b)(6) hospital.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.
Event or Problem Description
It was reported that a foley catheter was inserted in the operating room for urinary catheterization and temperature management and was being managed in the intensive care unit when urine leakage occurred from the drain bag.
Event or Problem Description
It was reported that a foley catheter was inserted in the operating room for urinary catheterization and temperature management and was being managed in the intensive care unit when urine leakage occurred from the drain bag.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error.There were no health consequences or impact to the patient.Therefore, this event is not reportable.Initial reporter name: (b)(6).Correction- d, g.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.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error.There were no impact to the patient.Therefore, this event is not reportable.Submitting the investigation details as additional information.The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Sample has been evaluated and observed there was tear on the backside (bottom area) of the drainage bag.The tear was penetrated until it was to the frontside of the drainage bag.However, the exact cause on how and when problem occurred could not be determine.The potential root cause for this failure mode could be bag scratch on the parts of bed.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action is required at this time.Correction: d,h.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.
Event or Problem Description
It was reported that a foley catheter was inserted in the operating room for urinary catheterization and temperature management and was being managed in the intensive care unit when urine leakage occurred from the drain bag.

• Brand Name: BARD® URINE METER WITH BAG
• Common Device Name: DRAIN BAG
• 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 ; 7707846100
• MDR Report Key: 23645895
• Report Number: 1018233-2025-10540
• Device Sequence Number: 4824762
• Product Code: KNX
• UDI-Device Identifier: 00801741033117
• UDI-Public: (01)00801741033117(11)250618(17)270628(10)MYKS5255
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 153204
• Device Lot Number: MYKS5255
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 02/10/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/04/2026; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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