BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7763439 · Received August 8, 2018

    Report

    Report Number
    1018233-2018-03478
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Report Date
    September 14, 2018
    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. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "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: SEPARATE NOTCHES WITHIN CIRCLES. PULL STRAPS THROUGH HOLES AND AROUND LEG. POSITION BAG ON LEG WITH FLUTTER VALVE AT TOP. ATTACH CATHETER OR EXTENSION TUBING TO TOP INLET. WHEN WEARING BAG BELOW KNEE, ATTACH BARD EXTENSION TUBING (CATALOG NO. 150615 OR 4A4194). 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. 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: (B)(4))."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAIN BAG DID NOT COME WITH INSTRUCTIONS FOR USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRAIN BAG DID NOT COME WITH INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606516 LEG BAG WITH FLIP-FLO VALVE, FABRIC LEG STRAPS, 19 OZ., STERILE DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741050855

    Patients

    Seq Age Sex Outcome Treatment
    1