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

Model Number	BFF5
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Head Injury (1879); Hemorrhage/Blood Loss/Bleeding (1888); Brain Injury (2219); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the flip-flo valve was being used with a coloplast indwelling catheter and the valve kept slipping from the catheter causing spills.One spill recently resulted in the patient slipping.The patient experienced a head injury requiring a blood transfusion and three hours of plastic surgery.Patient has been using this product since december of 2020 and would like to know if anything has changed.Per additional information received via email on (b)(6) 2021 from the complainant, they had previously used a night drainage bag which had effective groove lines around it that was not featured on the bard flip flo valve.This type of connection did not come undone even during sleep or when the patient twist and turned a lot.She thought these simple grooves on the connector was something bd should consider prototyping or trialing on the hard plastic connector part of the flip flo valve as this was where the problems have occurred.
Event or Problem Description
It was reported that the flip-flo valve was being used with a coloplast indwelling catheter and the valve kept slipping from the catheter causing spills.One spill recently resulted in the patient slipping.The patient experienced a head injury requiring a blood transfusion and three hours of plastic surgery.Patient has been using this product since (b)(6) of 2020 and would like to know if anything has changed.Per additional information received via email on 16sep2021 from the complainant, they had previously used a night drainage bag which had effective groove lines around it that was not featured on the bard flip flo valve.This type of connection did not come undone even during sleep or when the patient twist and turned a lot.She thought these simple grooves on the connector was something bd should consider prototyping or trialing on the hard plastic connector part of the flip flo valve as this was where the problems have occurred.
Additional Manufacturer Narrative
The reported event was inconclusive since the original sample was not returned.Visual evaluation of the returned sample noted one unopened (with original packaging), flip flo valve.Visual inspection of the sample noted no obvious visible observations.The flip flo valve was connected to a two-way silicone foley catheter and the connection was secure.The catheter was tugged, and there was no disconnection noted.The investigation is considered inconclusive since the original sample was not returned.A potential root cause for this failure could be inspection results (measurement, testing data).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ''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.Warning ¿ leave flip-flo¿ valve in open position.'' 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 flip-flo valve was being used with a coloplast indwelling catheter and the valve kept slipping from the catheter causing spills.One spill recently resulted in the patient slipping.The patient experienced a head injury requiring a blood transfusion and three hours of plastic surgery.Patient has been using this product since december of 2020 and would like to know if anything has changed.Per additional information received via email on 16sep2021 from the complainant, they had previously used a night drainage bag which had effective groove lines around it that was not featured on the bard flip flo valve.This type of connection did not come undone even during sleep or when the patient twist and turned a lot.She thought these simple grooves on the connector was something bd should consider prototyping or trialing on the hard plastic connector part of the flip flo valve as this was where the problems have occurred.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.The used sample was not returned.Visual evaluation of the returned sample noted one unopened (with original packaging), flip flo valve.Visual inspection of the sample noted no obvious visible observations.The flip flo valve was connected to an in-house two-way silicone foley catheter and the connection was secured.The catheter was tugged, and there was no disconnection noted.A potential root cause for this failure mode could be ¿inspection results (measurement, testing data) not verified by iqa assignee¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ''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.Warning ¿ leave flip-flo¿ valve in open position.'' corrections: f, h.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 actual/suspected device was inspected.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12571746
• Report Number: 1018233-2021-06181
• Device Sequence Number: 11580614
• 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,Followup
• Report Date (Section B): 05/02/2022

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 Expiration Date: 10/31/2025
• Device Model Number: BFF5
• Device Catalogue Number: BFF5
• Device Lot Number: NGEX1966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2021
• Supplement Date Received by Manufacturer: 03/09/2022; 05/03/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 04/04/2022; 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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: Required Intervention
• Patient Sex: Female