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

Model Number	BFF5
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
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.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 the customer had brought some flip flow catheter valves and stated that they were not draining patient's bladder unless attached to a bag.Stated that they had problems with their current catheter valves as it was not emptying unless attached to a leg or night bag.When the tap was opened, there was no flow but, as soon as they attached it to a bag, their bladder emptied.Stated that they previously had valves which would empty their bladder via the catheter directly just by turning the lever.The customer asked whether there was something wrong with the valve or was there another possible reason for this.The customer had tried several with the same result.The representative gave them the nurse advice line and advised that they might be able to help.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "inspection results (measurement, testing data) not verified by iqa assignee error of inspector".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "1.Wash hands.2.Attach flip-flo¿ valve to catheter ensuring that you do not touch either the catheter end or the valve connector.3.Wash hands thoroughly before and after operating flip-flo¿ valve.4.Empty bladder as frequently as advised by your doctor or nurse.5.To open the flip-flo¿ valve, push lever down.6.Allow urine to drain into toilet or an appropriate receptacle.7.To close the flip-flo¿ valve, pull lever up.8.A night drainage bag may be attached to the flexible connector to allow continuous urine drainage overnight." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the customer had brought some flip flow catheter valves and stated that they were not draining patient's bladder unless attached to a bag.Stated that they had problems with their current catheter valves as it was not emptying unless attached to a leg or night bag.When the tap was opened, there was no flow but, as soon as they attached it to a bag, their bladder emptied.Stated that they previously had valves which would empty their bladder via the catheter directly just by turning the lever.The customer asked whether there was something wrong with the valve or was there another possible reason for this.The customer had tried several with the same result.The representative gave them the nurse advice line and advised that they might be able to help.

• Brand Name: BARD® FLIP-FLO¿ CATHETER VALVE
• Common Device Name: 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: 16675158
• Report Number: 1018233-2023-02297
• Device Sequence Number: 20493678
• Product Code: KNX
• UDI-Device Identifier: 00801741131776
• UDI-Public: (01)00801741131776
• 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): 05/18/2023

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 Model Number: BFF5
• Device Catalogue Number: BFF5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/23/2023
• 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