MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER WITH BAG; DRAIN BAG

Catalog Number	153214A
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when placed in the emergency room, the flow of urine from the connecting tube to the urine collection bag was poor, and urine does not drip out.So, the problem was improved when the bag was replaced with a urine collection bag from another company.
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 placed in the emergency room, the flow of urine from the connecting tube to the urine collection bag was poor, and urine does not drip out.So, the problem was improved when the bag was replaced with a urine collection bag from another company.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received (4) photo samples.First photo sample shows the overview of the drainage bag with inlet tube and sample port connector.The second photo sample zooms in on sample port connector.The third photo sample shows zoom view of the depressed sample port connector.Fourth photo sample shows the verified date code.Visual evaluation of the returned sample noted one opened (without original packaging), used drainage bag with inlet tube and sample port connector.Visual inspection of the sample noted filled the drainage bag with water, the drainage bag was able to be filled up easily and drained easily with no difficulties.No restricted flow observed.No root cause could be found because the reported event was unconfirmed.The device history record review could not be performed without a lot number.As the reported event was unconfirmed a labeling review was not required.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® URINE METER WITH BAG
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21114180
• Report Number: 1018233-2024-08698
• Device Sequence Number: 20701544
• Product Code: KNX
• UDI-Device Identifier: 00801741033162
• UDI-Public: (01)00801741033162
• 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): 03/26/2025

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: 153214A
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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