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

Catalog Number	153204
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
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: 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 by the open heart operating room team that they had experienced multiple failures involving product a119216m.They noted two instances in which the foley catheter¿s urometer component had developed cracks, resulting in urine leakage during procedures.In one case last week, the catheter had needed to be replaced mid procedure.This morning, another foley had experienced the same issue, leading to leakage in a case that was ultimately canceled.However, the bag still had to be changed.Guidance was requested regarding next steps for resolution and investigation.
Event or Problem Description
It was reported by the open heart operating room team that they had experienced multiple failures involving product a119216m.They noted two instances in which the foley catheter¿s urometer component had developed cracks, resulting in urine leakage during procedures.In one case last week, the catheter needed to be replaced mid procedure.This morning, another foley had experienced the same issue, leading to leakage in a case that was ultimately canceled.However, the bag still had to be changed.Guidance was requested regarding next steps for resolution and investigation.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.The reported event is addressed within the labeling as it states: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Directions for use.17.Position hanger on bed rail at the foot of the bed.Note: exercise care to keep bag off the floor.18.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Corrections: a, d, e.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.

• 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: 24563583
• Report Number: 1018233-2026-01595
• Device Sequence Number: 9440483
• Product Code: KNX
• UDI-Device Identifier: 00801741033117
• UDI-Public: (01)00801741033117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/30/2026

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
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/31/2026
• 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