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

Model Number	BFF20
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
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.
Event or Problem Description
It was reported that the flip flo catheter valve package was empty, although the package was perfectly sealed.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.One sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned photo sample noted one unopened (with original packaging), flip-flo.Visual inspection of the photo sample noted that the product was not inside the sealed package.This is out of specification, which states, "no missing components allowed".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: "warning: this product should only be used after a licensed medical expert has assessed the bladder function.Indications for use in conjunction with an indwelling catheter.Contraindications ¿ decreased bladder capacity.¿ cognitive impairment.¿ no feeling in the bladder.¿ insufficient manual dexterity to operate the flip-flo¿ valve.Instructions ¿ wash your hands.¿ be careful not to attach the flip-flo¿ valve to the catheter touching the end of the catheter or the valve connector.¿ wash your hands thoroughly before and after operating the flip-flo¿ valve.¿ empty the bladder as often as recommended by your doctor or nurse.¿ push the lever down to open the flip-flo¿ cover.¿ drain the urine into the toilet or a suitable container.¿ pull the lever up to close the flip-flo¿ cover.¿ a night drainage bag can be connected to the flexible connector, so that urine can be drained continuously at night.Warning¿ leave the flip-flo¿ cover open." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the flip flo catheter valve package was empty, although the package was perfectly sealed.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13599999
• Report Number: 1018233-2022-00877
• Device Sequence Number: 5856703
• Product Code: KNX
• UDI-Device Identifier: 00801741131783
• UDI-Public: (01)00801741131783
• 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): 08/25/2022

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 Expiration Date: 09/30/2026
• Device Model Number: BFF20
• Device Catalogue Number: BFF20
• Device Lot Number: NGFW0688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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