MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FLIP-FLO¿ CATHETER VALVE; FLIP FLO CATHETER VALVE

Catalog Number	BFF5
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
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.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 sometimes when using the flip flow catheter valves the urine was trickling out and not flowing.
Event or Problem Description
It was reported that the sometimes when using the flip flow catheter valves the urine was trickling out and not flowing.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.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: directions for use warning: this product should not be used without assessment of bladder function by an appropriate medical professional.Indications for use with an indwelling catheter.Contraindications reduced bladder capacity.Cognitive impairment.No bladder sensation.Insufficient manual dexterity to operate the flip-flo valve.Instructions wash hands.Attach flip-flo valve to catheter ensuring that you do not touch either the catheter end or the valve connector.Wash hands thoroughly before and after operating flip-flo valve.Empty bladder as frequently as advised by your doctor or nurse.To open the flip-flo valve, push lever down.Allow urine to drain into toilet or an appropriate receptacle.To close the flip-flo valve, pull lever up.A night drainage bag may be attached to the flexible connector to allow continuous urine drainage overnight.Warning leave flip-flo valve in open position.It is recommended that the flip-flo valve is changed every 5-7 days.Simply disconnect the valve from the catheter and discard.Attach a new valve following the above instructions.Correction: d.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® FLIP-FLO¿ CATHETER VALVE
• Common Device Name: FLIP FLO CATHETER VALVE
• 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: 22384682
• Report Number: 1018233-2025-05445
• Device Sequence Number: 12966246
• Product Code: KNX
• UDI-Device Identifier: 00801741131776
• UDI-Public: (01)00801741131776(11)240905(17)290630(10)NGJU3636
• 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): 08/25/2025

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: BFF5
• Device Lot Number: NGJU3636
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2024
• 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