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

Catalog Number	154114A
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
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.All available udi information is being provided.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 in or department, inserted one of these foley catheters in a patient and could not get the balloon to inflate.They opened a 2nd tray and had the same issue with that tray.They did not keep any of the used catheters.They only have the outer packages, but they do not have the lot numbers on the outer packaging.Per customer follow up information received via email on 17nov2025, it was reported that they have the outer wrappers for the 2 foley trays, but unfortunately the staff did not retain the defective catheters.Lot number was not available.Two urinary catheter insertions were required.Removal and reinsertion of urinary catheter were performed.They were performed troubleshooting.Attempted to insert a foley and the balloon would not inflate.Foley removed.Opened another foley kit and while testing the balloon a leak was seen, and this balloon would also not inflate.Opened another foley kit, balloon tested and inflated appropriately.Foley inserted and then unable to draw urine from the port with syringe.
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.The reported event is addressed within the labeling as it states: 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.Note: if specimen is required, see directions for using urine sample port.5.Periodic observations of this system should be made to ensure the urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.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 in or department, inserted one of these foley catheters in a patient and could not get the balloon to inflate.They opened a 2nd tray and had the same issue with that tray.They did not keep any of the used catheters.They only have the outer packages, but they do not have the lot numbers on the outer packaging.Per customer follow up information received via email on 17nov2025, it was reported that they have the outer wrappers for the 2 foley trays, but unfortunately the staff did not retain the defective catheters.Lot number was not available.Two urinary catheter insertions were required.Removal and reinsertion of urinary catheter were performed.They were performed troubleshooting.Attempted to insert a foley and the balloon would not inflate.Foley removed.Opened another foley kit and while testing the balloon a leak was seen, and this balloon would also not inflate.Opened another foley kit, balloon tested and inflated appropriately.Foley inserted and then unable to draw urine from the port with syringe.

• 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: 23645913
• Report Number: 1018233-2025-10537
• Device Sequence Number: 4825237
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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): 04/10/2026

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: 154114A
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Race: White