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

Model Number	BFF20
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
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 package was found empty.There was no flip-flo in the package.
Event or Problem Description
It was reported that the package was found empty.There was no flip-flo in the package.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Visual evaluation of the photo sample noted one original package for a flip-flo catheter valve.Visual inspection of the packaging noted that the flip flo valve product was not present inside the packaging.However, without the physical sample for evaluation, it cannot be determined whether the packaging was opened or not.A potential root cause for the reported failure could be, ¿operation omitted due to unbalanced operations.¿ 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 is a single use device.Do not re-sterilize any portion of this device.Reuse and or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD® FLIP-FLO¿ CATHETER VALVE
• Common Device Name: FLIP-FLO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9706677
• Report Number: 1018233-2020-01002
• Device Sequence Number: 2872312
• 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: company representative,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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: 08/31/2024
• Device Model Number: BFF20
• Device Catalogue Number: BFF20
• Device Lot Number: NGDV2277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/22/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1