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

Catalog Number	153214A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
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 10-15 times in the last three weeks where the drain bag connected to the meter leaked.The customer reported issues with lot# ngjv4633, lot# ngjw3241.The clinicians had come in contact with patient urine.Per follow up via phone on 12feb2025, it was reported that the bags had rips in them and when they tried to empty the bag, the urine would spill on the nurses and patients.Their representative came out and replaced the defective foleys.Lot numbers were given to the bd the representative and customer did not have them at hand to give them to representative.
Event or Problem Description
It was reported that the 10-15 times in the last three weeks where the drain bag connected to the meter leaked.The customer reported issues with lot# ngjv4633, lot# ngjw3241.The clinicians had come in contact with patient urine.Per follow up via phone on (b)(6)2025, it was reported that the bags had rips in them and when they tried to empty the bag, the urine would spill on the nurses and patients.Their representative came out and replaced the defective foleys.Lot numbers were given to the bd the representative and customer did not have them at hand to give them to representative.
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.No additional actions can be taken at this time since root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "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." 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
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: 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.Correction: b, e, 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.
Event or Problem Description
It was reported that the 10-15 times in the last three weeks where the drain bag connected to the meter leaked.The customer reported issues with lot# ngjv4633, lot# ngjw3241.The clinicians had come in contact with patient urine.Per follow up via phone on (b)(6) 2025, it was reported that the bags had rips in them and when they tried to empty the bag, the urine would spill on the nurses and patients.Their representative came out and replaced the defective foleys.Lot numbers were given to the bd the representative and customer did not have them at hand to give them to representative.

• Brand Name: BARD® URINE METER WITH BAG
• Common Device Name: METER 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 30014 ; 7707846100
• MDR Report Key: 21594239
• Report Number: 1018233-2025-01663
• Device Sequence Number: 8479333
• Product Code: KNX
• UDI-Device Identifier: 00801741033162
• UDI-Public: (01)00801741033162(11)241003(17)260417(10)NGJV4633
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/17/2026
• Device Catalogue Number: 153214A
• Device Lot Number: NGJV4633
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 06/20/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 03/21/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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