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

Catalog Number	BFF5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	03/06/2025
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 a batch of bard flip flow catheter valve, that had cracks in them.They were returned by a patient as when patient had been using, they have had leaked, and patient had noticed these cracks.2 boxes of batch ngju3636 where all the taps were affected.Patient was exposed to hazardous, blood, or bodily fluids.It was unknown what medical intervention was provided.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), flip flow catheter valve.Visual inspection of the one-photo sample noted that flip flow valve had a small scratch tap valve.This does not meet specification which states no missing, damaged, torn, broken, incomplete or incorrect components are not allowed.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: instructions for use: warning: this product should not be used without assessment of bladder function by an 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.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: b, d, 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 a batch of bard flip flow catheter valve, that had cracks in them.They were returned by a patient as when patient had been using, they have had leaked, and patient had noticed these cracks.2 boxes of batch ngju3636 where all the taps were affected.Patient was exposed to hazardous, blood, or bodily fluids.No medical intervention was reported.

• Brand Name: BARD® FLIP-FLO¿ CATHETER VALVE
• Common Device Name: FLIP FLOW 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 30014 ; 7707846100
• MDR Report Key: 21721835
• Report Number: 1018233-2025-02109
• Device Sequence Number: 9437577
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: Lay User/Patient
• Device Catalogue Number: BFF5
• Device Lot Number: NGJU3636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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