MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG; DRAIN BAG

Catalog Number	153504
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2025
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.Initial reporter 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.
Event or Problem Description
It was reported that urine leaked from near the foley catheter connection.Location unknown.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr is not reportable as the allegation is against a drain bag.Submitting the investigation details as additional information.The reported event was unconfirmed because the reported failure could not be reproduced.The returned device was functionally tested, and the product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.The labeling and instructions for use were found to be adequate.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.Corrections: d, g, h this report references a us equivalent device.The us udi equivalent for this product number is used.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 urine leaked from near the foley catheter connection.Location unknown.

• Brand Name: BARD® URINARY DRAINAGE 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: 23097172
• Report Number: 1018233-2025-08370
• Device Sequence Number: 20977900
• Product Code: KNX
• UDI-Device Identifier: 00801741029530
• UDI-Public: (01)00801741029530
• 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
• Report Date (Section B): 01/20/2026

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: 153504
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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