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

Catalog Number	154114
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that urine was leaking from the connection between the foley catheter and the bag.
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 urine was leaking from the connection between the foley catheter and the bag.
Additional Manufacturer Narrative
The complete initial reporter's facility name is (b)(6).The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Corrections: d, e, g, h.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 urine was leaking from the connection between the foley catheter and the bag.
Additional Manufacturer Narrative
The reported event is unconfirmed.Received 1 urine meter bag with inlet tube, sample port connector and an all silicone foley catheter attached.Verified date code 0225j.Verified material number for catheter 119314 and manufacturing lot number ngjw2609.Visual inspection noted no obvious observations.The urine lumen was filled with water and no leakage was present.The reported event could not be duplicated.As the reported event is unconfirmed, a risk and labeling review is not required.A review of the device history record was not necessary due to the reported event being unconfirmed.Based on the investigation results no additional action is required at this time.Correction: d.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® 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: 22748278
• Report Number: 1018233-2025-06588
• Device Sequence Number: 18294444
• Product Code: KNX
• UDI-Device Identifier: 00801741029592
• UDI-Public: (01)00801741029592(11)250219(17)270628(10)MYJZ4528
• 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): 01/29/2026

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: 154114
• Device Lot Number: MYJZ4528
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 01/29/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 10/10/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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