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

Catalog Number	BFF5
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer could not connect the flip-flo to an overnight bag or a leg bag.It was stated that the customer had big issue was with the night bag and connection to the flip-flo valve could bend and block off their bladder completely and it did not allow voiding/emptying properly, also stated that customer was having to taped it to ensure it stay on and stiff.The representative did offer the solution of removing the flip-flo valve and connecting directly to the drainage, but they stated it would still not fix the issue with the valve bending overall.Per follow up via phone on 15feb2025, it was reported that the customer provided suggestions on how to make the drain bags better with the flip flo valves.Offered to send in a drawing on how to make they better.
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 dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: instructions for use: warning: this product should not be used without assessment of bladder function by appropriate medical professional.Instructions: wash hands thoroughly before and after operating flip-flo valve.Attach flip-flo valve to catheter ensuring that you do not touch either the catheter end or the valve connector.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.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: BARD® 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: 21698683
• Report Number: 1018233-2025-02048
• Device Sequence Number: 8667923
• Product Code: KNX
• UDI-Device Identifier: 00801741131776
• UDI-Public: (01)00801741131776
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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
• 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: 03/05/2025
• Initial Report FDA Received Date: 03/26/2025
• 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 Sex: Unknown