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

Catalog Number	153204
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported after opening the drain bag, the precision urine meter and tube were damaged and detached, so usage was refrained.
Event or Problem Description
It was reported after opening the drain bag, the precision urine meter and tube were damaged and detached, so usage was refrained.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to capture the investigation details.There were no health consequences or impact to the patient.This event is not reportable.The reported event was confirmed ¿ cause unknown.The product had caused the reported failure.Sample was evaluated and observed connecting part between urine meter and inlet tube was broken that allowed water to leak out.The exact cause of how and when the problem occurred could not be determined.A potential root cause for this failure could be defective / torn / broken components and also might be contributed by inappropriate material selection, inadequate solvent selection or improper mating dimensions.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.The initial reporter facility name (b)(6) hospital.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: 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 30014 ; 7707846100
• MDR Report Key: 23063378
• Report Number: 1018233-2025-08141
• Device Sequence Number: 9663172
• Product Code: KNX
• UDI-Device Identifier: 00801741033117
• UDI-Public: (01)00801741033117(11)250515(17)300428(10)MYKR0226
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/28/2025

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: 153204
• Device Lot Number: MYKR0226
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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