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

Catalog Number	153220J
Medical Device Problem Codes	Partial Blockage (1065); Deformation Due to Compressive Stress (2889)
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.Udi format updated with available product information per gudid.H11: sections 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 it was unclear whether it is the catheter or the bag, but it seemed there was a blockage.
Event or Problem Description
It was reported that it was unclear whether it is the catheter or the bag, but it seemed there was a blockage.Based on sample evaluation received on 14oct2025, this complaint was related to drainage bag issue.There was no catheter returned for evaluation.Sample evaluation observed the inlet tube was kink.
Additional Manufacturer Narrative
The reported event was confirmed ¿ unknown cause.The reported failure was able to be reproduced.The product had caused the reported failure.The sample was evaluated, and it was observed that the inlet tube was kinked at the upper section of the urine meter.Water was introduced into the inlet tube and was able to flow out easily.However, the exact cause of how and when problem occurred could not be determined.The potential root cause for this failure mode could be due to operator's handling method/supplier defect.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore no additional action required at this time.Correction: d.All available udi information is being provided 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 it was unclear whether it is the catheter or the bag, but it seemed there was a blockage.Based on sample evaluation received on 14oct2025, this complaint was related to drainage bag issue.There was no catheter returned for evaluation.Sample evaluation observed the inlet tube was kink.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d, f, g, 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.

• Brand Name: BARD® URINE METER WITH BAG
• Common Device Name: URINE METER WITH 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: 23073180
• Report Number: 1018233-2025-08229
• Device Sequence Number: 4645636
• Product Code: KNX
• UDI-Device Identifier: 00801741033117
• UDI-Public: (01)00801741033117(11)250619(17)270628(10)MYKQ3331
• 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): 10/17/2025

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: 153220J
• Device Lot Number: MYKQ3331
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 10/17/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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