BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG BAG WITH FLIP-FLO¿ VALVE

    MDR report key: 19320459 · Received May 15, 2024

    Report

    Report Number
    1018233-2024-02728
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 26, 2024
    Report Date
    May 24, 2024
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FAQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE ¿OBSTRUCTION IN TUBE/KINKED TUBING". HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. 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: "DIRECTIONS FOR USE: 1. SEPARATE NOTCHES WITHIN CIRCLES. PULL STRAPS THROUGH HOLES AND AROUND LEG. 2. POSITION BAG ON LEG WITH FLUTTER VALVE AT TOP. 3. ATTACH CATHETER OR EXTENSION TUBING TO TOP INLET. WHEN WEARING BAG BELOW KNEE, ATTACH BARD® EXTENSION TUBING (CATALOG NO. 150615 OR 4A4194). WHEN USING EXTENSION TUBING, MAKE SURE TO CONNECT TUBE AT LEAST TO THE 3RD TAPER OF THE CONNECTOR. 4. TO EMPTY DISPOZ-A-BAG®, PUSH GREEN LEVER ON FLIP-FLO¿ VALVE OUT AND DOWN. IMPORTANT: BE SURE TO RECLOSE FLIP-FLO¿ VALVE AFTER EMPTYING BAG. 5. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE, LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS." 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT RECEIVED 57150832 LEG BAG, PATIENT HAD TRIED BEFORE AND STATED THAT URINE BACKED UP AND CAUSED LEAKAGE HENCE PREFERRED 6012588 LEG BAGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT RECEIVED 57150832 LEG BAG, PATIENT HAD TRIED BEFORE AND STATED THAT URINE BACKED UP AND CAUSED LEAKAGE HENCE PREFERRED 6012588 LEG BAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1383506 LEG BAG WITH FLIP-FLO¿ VALVE LEG BAG FAQ C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other