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

Catalog Number	BFF5
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product bard flip-flo catheter valve bxbff5 with lot number nghz1048 and expiration date (b)(6) 2028, had regular problems as they do not go the way they are supposed to go, they are stiff hard to get closed after 1 or 2 weeks.Also, they brought it up with the urology nurse they were aware.It was getting expensive as the patient needed 2 or 3 in 6 weeks.Among which one already broken off.
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.
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 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 states the following: bard flip flo catheter valve 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.Correction- d, e, 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 the product bard flip-flo catheter valve bxbff5 with lot number nghz1048 and expiration date 30/11/2028, had regular problems as they do not go the way they are supposed to go, they are stiff hard to get closed after 1 or 2 weeks.Also, they brought it up with the urology nurse they were aware.It was getting expensive as the patient needed 2 or 3 in 6 weeks.Among which one already broken off.

• 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 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: 21605301
• Report Number: 1018233-2025-01688
• Device Sequence Number: 21040853
• Product Code: KNX
• UDI-Device Identifier: 00801741131776
• UDI-Public: (01)00801741131776(11)240207(17)281130(10)NGHZ1048
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: Health Professional
• Device Catalogue Number: BFF5
• Device Lot Number: NGHZ1048
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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