BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9757124 · Received February 26, 2020

    Report

    Report Number
    1018233-2020-01346
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Report Date
    March 19, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741050855
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿BAG WILL NOT EXPAND/VINYL STUCK TOGETHER¿ WITH A POTENTIAL ROOT CAUSE OF "STATIC OR POSITIVE AIR PRESSURE". 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: ¿RELEASED BARD® DISPOZ-A-BAG® DISPOSABLE URINARY LEG BAG WITH FLIP-FLO¿ DRAINAGE VALVE A MEDICAL GRADE VINYL LEG BAG TO BE USED WITH MALE EXTERNAL CATHETERS. FOLEY CATHETERS OR MOST OTHER TYPES OF URINARY CATHETERS. 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. BARD DISPOZ-A-BAG ACCESSORIES: ¿ LEG BAG HOLDER ¿ 1-3/4¿ WIDE LEG BAG STRAP ¿ DELUXE FABRIC LEG BAG STRAPS ¿ EXTENSION TUBING CONTACT C.R. BARD, INC. AT THE NUMBER BELOW FOR INFORMATION ON THESE AND OTHER ACCESSORIES. IL7014 LABELING ISSUE DATE: 10/96 IN THE EVENT 3 YEARS HAVE ELAPSED BETWEEN THIS DATE AND THE PRODUCT USE, THE USER SHOULD CONTACT C.R. BARD, INC. TO SEE IF ADDITIONAL PRODUCT INFORMATION IS AVAILABLE. (TELEPHONE NUMBER: 1-800-526-4455). FLUTTER VALVE INLET". 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

    THE PATIENT STATED THE LEG BAG HURT HIM AT NIGHT, AND HE HAD TO ADJUST THE BAG BECAUSE IT GOT STUCK. HE ALSO STATED THAT IT DID NOT FILL UP THE WAY IT SHOULD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT STATED THE LEG BAG HURT HIM AT NIGHT, AND HE HAD TO ADJUST THE BAG BECAUSE IT GOT STUCK. HE ALSO STATED THAT IT DID NOT FILL UP THE WAY IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223489 LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE DISPOS-A-BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741050855

    Patients

    Seq Age Sex Outcome Treatment
    1