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

Catalog Number	BFF20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "materials of construction are not biocompatible".It is unknown whether the device had met relevant specifications.The product was used for treatment purpose.It was unknown whether the product had caused the reported failure.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "bard® flip-flo¿ catheter valve instructions: directions for use: warning: this product should not be used without assessment of bladder function by an appropriate medical professional.Indications: for use with indwelling catheters.Contraindications: decreased bladder capacity.Cognitive impairment.No bladder sensation.Insufficient manual operation ability flip-flo¿ valve.Instructions: wash hands.Attach flip-flo¿ valve to catheter ensuring that you do not touch either the catheter end of 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." 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.H3 other text: the device was not returned.
Event or Problem Description
It was reported that in the online survey a physician stated that the patient experienced urinary tract infection (uti) prior to the device placement and symptomatic urinary tract infection (uti) complications were directly attributable to the device occurred 4 days after the device placement and no medical or surgical intervention was needed in relation to bff20 - flip-flo catheter valve with 180° lever tap.It was unknown what medical intervention was provided for urinary tract infection.

• 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 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17624102
• Report Number: 1018233-2023-06344
• Device Sequence Number: 15274620
• Product Code: KNX
• UDI-Device Identifier: 00801741131783
• UDI-Public: (01)00801741131783
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BFF20
• 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: 08/03/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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