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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
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: 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 patient unable to drain 1/2 full urine bag into measurable container.Able to unclamp the clamp, but no urine drains from tube.Appears tube was not filled with urine? possible blockage at bottom of urine bag that connects to the tube that was clamped.Multiple registered nurse attempted to trouble shoot problem.Foley had to be removed and a new one placed.A urometer foley was used due to the concerns of that lot # of foley tray systems that were currently stocked on the unit.
Event or Problem Description
It was reported that the patient unable to drain 1/2 full urine bag into measurable container.Able to unclamp the clamp, but no urine drains from tube.Appears tube was not filled with urine? possible blockage at bottom of urine bag that connects to the tube that was clamped.Multiple registered nurse attempted to trouble shoot problem.Foley had to be removed and a new one placed.A urometer foley was used due to the concerns of that lot # of foley tray systems that were currently stocked on the unit.Per additional information received via email on 14nov2025, it was reported that the foley catheter had to be removed because it would not drain.A new foley catheter had to be placed.They troubleshooting was performed by several nurses attempting to drain the defective foley catheter.They described the defective foley catheter in my initial product concern.The catheter would not drain despite multiple attempts by several nurses to drain it.There was urine in the bag, the clamp was unclamped, but still no urine was draining from the urine bag.A urometer was placed due to the multiple foley catheter defects we were experiencing.
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.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling as it state.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.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d.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.

• 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: 23488460
• Report Number: 1018233-2025-10005
• Device Sequence Number: 18766689
• Product Code: KNX
• UDI-Device Identifier: 00801741029509
• UDI-Public: (01)00801741029509(11)250517(17)271031(10)NGKR2067
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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
• Device Lot Number: NGKR2067
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2025
• 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