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

Catalog Number	154002
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ref 154002 lot ngw2458 is defective, the bag has to be tilted to the side to get it to drain completely.In addition, there is a clip that connects to the catheter it won't fit on and when it does, it rubs on the skin and caused a wound.
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 that the ref #154002 lot ngw2458 is defective.The bag has to be tilted to the side to get it to drain completely.In addition, there is a clip that connects to the catheter it won't fit on and when it does, it rubs on the skin and caused a wound.
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 labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: f,h 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.
Additional Manufacturer Narrative
Upon further review, it was found that 1018233-2025-06350 had no allegation against device.Therefore, a retraction is being submitted.Correction: h.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 the ref #(b)(4) lot ngw2458 is defective.The bag has to be tilted to the side to get it to drain completely.In addition, there is a clip that connects to the catheter it won't fit on and when it does, it rubs on the skin and caused a wound.Per customer via phone on 27oct2025, it was reported that he did not file a complaint regarding a drain bag.Customer stated that he had an issue with depends padding ordered from mckesson.

• Brand Name: BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• 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: 22676004
• Report Number: 1018233-2025-06350
• Device Sequence Number: 8864484
• Product Code: KNX
• UDI-Device Identifier: 00801741029509
• UDI-Public: (01)00801741029509
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2025

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: 154002
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 10/09/2025; 11/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/10/2025
• 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