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

Catalog Number	153504
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a doctor inserted a balloon to collect urine and manage urination.When the needle sample port was disinfected with an alcohol swab and the urine syringe was inserted in the drain bag, the plastic of the sample port broke.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter phone: (b)(6).Initial reporter fax: (b)(6).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.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Three photos were received of the drainage bag where it was visible that the sample port stem had broken off.Visual inspection of the physical sample noted blue stem luer and stem housing was broken from the sample port connector upon return.This does not meet specification which states that "the product must conform to the applicable drawing.Separations in the assemblies are not allowed".The reported event is addressed within the labeling.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d,g,h.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 a doctor inserted a balloon to collect urine and manage urination.When the needle sample port was disinfected with an alcohol swab and the urine syringe was inserted in the drain bag, the plastic of the sample port broke.

• 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: 22860920
• Report Number: 1018233-2025-06931
• Device Sequence Number: 18449310
• Product Code: KNX
• UDI-Device Identifier: 00801741029530
• UDI-Public: (01)00801741029530(11)250322(17)270628(10)MYKN1583
• 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): 02/20/2026

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
• Device Lot Number: MYKN1583
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2025
• 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