BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P WITH TOBRAMYCIN 1 PACK

    MDR report key: 3659135 · Received March 5, 2014

    Report

    Report Number
    0002249697-2014-00623
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PACKAGING DAMAGE INVOLVING A SIMPLEX PACKAGING WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE BATCH MANUFACTURING RECORD INDICATES THAT THIS BATCH WAS MANUFACTURED AND SHIPPED TO STOCK WITH NO REPORTED DISCREPANCIES. REVIEW DETERMINED THAT THERE WERE NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT. OTHER THAN THAT THE SIMPLEX UNIT CARTON WAS RECEIVED DAMAGED AT THE HOSPITAL IN THAT THE VIAL WAS BROKEN AND THE LIQUID HAD DRIED UP, NO FURTHER INFORMATION WAS PROVIDED. BASED ON THIS, THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED, BUT IT APPEARS THAT THIS PRODUCT WAS DAMAGED DUE TO INAPPROPRIATE HANDLING OR STORAGE DURING DISTRIBUTION/TRANSPORTATION. NCR (B)(4) WAS RAISED IN (B)(6) 2010 TO ADDRESS A TREND NOTED FOR DAMAGE TO SIMPLEX PACKAGING. THIS TREND WAS BASED ON THE VOLUME OF COMPLAINTS RECEIVED ASSOCIATED WITH PACKAGING DAMAGE FOR SIMPLEX PRODUCT. UPON APPLICATION OF ADVERSE TREND DETECTION IT WAS DETERMINED THAT THE RATE IS WITHIN THE RISK ACCEPTABILITY CRITERIA. PACKAGE DESIGN REVIEW WAS CARRIED OUT AS PART OF THE NCR AND IT WAS DETERMINED THAT FURTHER DESIGN REVIEW WILL BE COMPLETED UNDER PACKAGING INNOVATION QUALITY IMPROVEMENT PROJECTS. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME AS NO PRODUCT AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP OPENED THE SIMPLEX PACKAGING GET READY FOR A CASE. THE VIAL WAS BROKEN AND THE LIQUID HAD DRIED IN THE PACKAGE. PATIENT WAS IN THE OR BUT NOT AFFECTED AS BACK UP DOSAGE WAS IMMEDIATELY AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP OPENED THE SIMPLEX PACKAGING GET READY FOR A CASE. THE VIAL WAS BROKEN AND THE LIQUID HAD DRIED IN THE PACKAGE. PATIENT WAS IN THE OR BUT NOT AFFECTED AS BACK UP DOSAGE WAS IMMEDIATELY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132536 SIMPLEX P WITH TOBRAMYCIN 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH MHT079

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other