BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE

    MDR report key: 14716544 · Received June 16, 2022

    Report

    Report Number
    1018233-2022-04700
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 3, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FAQ
    UDI-DI
    00801741050855
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE DEVICE DID NOT FAIL TO MEET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: "PACKAGE CONTAINS ONE LEG BAG AND TWO FABRIC STRAPS". 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEG BAG WAS MISSING THE EXTENSION TUBING. THIS ISSUE HAD HAPPENED ON BOTH ORDERS 3061013 AND 3074184.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEG BAG WAS MISSING THE EXTENSION TUBING. THIS ISSUE HAD HAPPENED ON BOTH ORDERS 3061013 AND 3074184.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253713 LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE LEG BAG FAQ C.R. BARD, INC. (COVINGTON) -1018233 150719 UNK 00801741050855

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other