BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML MIXING CONTAINER

    MDR report key: 50686 · Received November 21, 1996

    Report

    Report Number
    MW1010309
    Event Type
    Malfunction
    Date Received
    November 21, 1996
    Manufacturer
    MC GAW, INC.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    CO'S TESTING INDICATES THAT, ALTHOUGH THE CLOSURE IS LOOSE ON THE CONTAINER, THIS HAS NOT COMPROMISED THE INTEGRITY OF THE UNIT, AS THE VACUUM IS INTACT AND REMAINS AT SPECIFICATION. REVIEW OF THE IN-PROCESS MFG RECORDS FOR LOT J6H042 SHOWED NO MFG NON-CONFORMANCES ASSOCIATED WITH THIS REPORT. THE LOOSE CLOSURE IS EITHER DUE TO DAMAGE DURING SHIPPING/HANDLING OR IMPROPER CRIMPING DURING ASSEMBLY. AS A PART OF CO'S CONTINUAL QUALITY IMPROVEMENT PROGRAM, OUR GLASS FILLING MFG OPERATION HAS BEEN RELOCATED TO A NEW CLEAN ROOM LOCATION WITH COMPLETE UPGRADES TO ALL THE MFG EQUIPMENT. THE EQUIPMENT AND OPERATIONS HAVE BEEN RE-CALIBRATED AND RE-VALIDATED. CO'S EVALUATION CONCLUDED THE CAUSE OF THE DISASSEMBLY TO BE DUE TO INSUFFICIENT SOLVENT APPLICATION BETWEEN THE TUBING AND BAG ASSEMBLY. THIS TYPE OF DEFECT IS DIRECTLY RELATED TO AN OPERATOR/MFG ERROR. AS A RESULT OF CO'S FINDINGS, THE PRODUCTION WORKERS IN THE MFG AREA AND PRODUCT ENGINEERS HAVE BEEN INFORMED OF THIS COMPLAINT. ALSO, THE ASSEMBLERS HAVE BEEN PROVIDED ADD'L TRAINING TO HELP ENSURE THAT THIS PROBLEM DOES NOT OCCUR IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 ML MIXING CONTAINER EVACUATED TPN BAG KPE MC GAW, INC. Y94-005-253 J5170F

    Patients

    Seq Age Sex Outcome Treatment
    1 *