MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG WITH FLIP-FLO DRAINAGE VALVE

Catalog Number	150619
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
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.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 the patient advised that they are had issues with the leg bags blocking and not draining.
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: "indications for use: leg bags are indicated for urine collection with urinary catheters as determined by a physician.Contraindication: no known contraindications.Precaution: keep leg bag below the bladder to ensure urine is flowing freely.Make sure all connections are compatible and fit securely.Ensure leg bag is secure to prevent slippage.A loose strap may cause leg bag to fall.Discard and replace bag if it becomes discolored, brittle or contains bad odor (even after cleaning).When leg bag is used with a foley catheter connection, it should remain in place for up to 7 days; dispose upon disconnection.When leg bag is used with a penile sheath/intermittent catheter, clean bag and disinfect as needed and replace every 7 days.Leg straps (if provided) are single use up to 7 days.Warnings: remove leg straps for conditions including, but not limited to: discoloration, swelling, numbness, rash, discomfort or if the leg strap is soiled.For pre-existing conditions, and/or if experiencing problems with use of the device, please consult your healthcare professional for assistance." 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 the patient advised that they are had issues with the leg bags blocking and not draining.

• Brand Name: LEG BAG WITH FLIP-FLO DRAINAGE VALVE
• Common Device Name: LEG 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: 21321523
• Report Number: 1018233-2025-00641
• Device Sequence Number: 21006736
• Product Code: FAQ
• UDI-Device Identifier: 00801741050831
• UDI-Public: (01)00801741050831(11)240822(17)290531(10)NGJT2610
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: Lay User/Patient
• Device Catalogue Number: 150619
• Device Lot Number: NGJT2610
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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