BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10431829 · Received August 20, 2020

    Report

    Report Number
    1018233-2020-05300
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Report Date
    November 28, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741050794
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "DEFECTIVE COMPONENTS FROM THE SUPPLIER". THE LOT NUMBER WAS 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). 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." CORRECTIONS: D10, H3. 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 CUSTOMER BELIEVED THE BAGS RECEIVED FROM LIBERATOR MEDICAL ARE THINNER AND LOWER QUALITY THAN THOSE RECEIVED FROM VITALITY. CUSTOMER ALSO STATED THAT THE PACKAGING MATERIALS WERE LOW GRADE CARDBOARD BOXES AND SUBPAR TAPE WHICH MADE HIM UNCOMFORTABLE OPENING THE BOXES AS THEY COULD BE EXPOSED TO COVID19 VIRUS. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 28JUL2020, ONE OF THE BAGS HAD A MOLD LIKE SUBSTANCE GROWING INSIDE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER BELIEVED THE BAGS RECEIVED FROM LIBERATOR MEDICAL ARE THINNER AND LOWER QUALITY THAN THOSE RECEIVED FROM VITALITY. CUSTOMER ALSO STATED THAT THE PACKAGING MATERIALS WERE LOW GRADE CARDBOARD BOXES AND SUBPAR TAPE WHICH MADE HIM UNCOMFORTABLE OPENING THE BOXES AS THEY COULD BE EXPOSED TO COVID19 VIRUS. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 28JUL2020, ONE OF THE BAGS HAD A MOLD LIKE SUBSTANCE GROWING INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899592 LEG BAG WITH FLIP-FLO VALVE AND LATEX STRAPS, 19 OZ., STERILE DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 150319 UNK 00801741050794

    Patients

    Seq Age Sex Outcome Treatment
    1