BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2464221 · Received February 22, 2012

    Report

    Report Number
    2090040-2012-00005
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Report Date
    January 26, 2012
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    OEX
    PMA / PMN Number
    K092425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. THE DEVICE WAS RETURNED IN ITS ORIGINAL PACKAGING. THE OUTER BOX DID NOT APPEAR TO HAVE ANY DAMAGE. THE TYVEK POUCH WAS FOUND TO BE RIPPED NEAR THE HANDLE OF THE DEVICE. IT APPEARED THAT THE TEAR ORIGINATED FROM A CORNER OF THE SOLID BLEACHED SULFATE (SBS) DEVICE RESTRAINT. AS IT APPEARS THE TEAR ORIGINATED FROM A CORNER OF THE SBS RESTRAINT, IT IS LIKELY THAT A FORCE WAS APPLIED TO THE RESTRAINT WHICH CAUSED THE TYVEK POUCH TO BECOME PUNCTURED AND TEAR. THE OUTER SBS BOX DID NOT APPEAR DAMAGED, WHICH INDICATES THAT THE DAMAGE TO THE INNER PACKAGING MAY HAVE OCCURRED WHILE THE DEVICE WAS OUTSIDE OF THE SBS BOX. IT IS POSSIBLE THAT THE TEAR ORIGINATED AS A PINHOLE CREATED AT SOME POINT BY THE SBS RESTRAINT. IF THIS PINHOLE WENT UNDETECTED THROUGH PRE AND POST-STERILIZATION INSPECTION, IT IS POSSIBLE THAT WHEN THE DEVICE WAS INSERTED INTO THE SBS BOX, THE PINHOLE CAUGHT ON THE CORNER OF THE RESTRAINT AND TORE FURTHER. HOWEVER, IT IS ALSO POSSIBLE THAT THIS FAILURE OCCURRED DUE TO MISHANDLING SUBSEQUENT TO REPROCESSING. THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE SHOWS THAT THE DEVICE PASSED ALL INSPECTION PRIOR TO SHIPMENT. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL MDR FOR THIS COMPLAINT WAS SUBMITTED, IT WAS DETERMINED TO ADD THIS COMPLAINT TO AN OPEN CAPA THAT STRYKER SUSTAINABILITY SOLUTIONS (SSS) HAD FOR HOLES IN PACKAGING. ADDITIONAL INFORMATION WAS OBTAINED (B)(6) 2012 REGARDING THE ABOVE LISTED CAPA THAT CLOSED ON (B)(6) 2012. BASED OFF THE CAPA INVESTIGATION, THE ROOT CAUSE WAS IDENTIFIED AS THE PACKAGING DESIGN OF THE RESTRAINT CARD UTILIZED WITHIN THE STERILE BARRIER TO RESTRICT DEVICE MOTION IN SHIPPING AND HANDLING. SPECIFICALLY THE 90 DEGREE CORNER FEATURES OF THE RESTRAINT HAVE BEEN CITED AS A DESIGN FLAW IN THE RESTRAINT, PROVIDING A SHARP LOCATION AND THE POTENTIAL FOR BREACH WHEN SUBJECTED TO THE DYNAMICS OF THE STERILIZATION PROCESS AND HANDLING. A NEW RESTRAINT ASSEMBLY COMPRISED OF SOLID BLEACH SULFATE WAS DESIGNED AND TESTED FEATURING ROUNDED EDGES AND CONTOURS. THE LENGTH OF THE RESTRAINT ASSEMBLY WAS INCREASED TO PROTECT THE DEVICE CONNECTOR AND TO REDUCE THE POUCH FOLDING WITHIN THE CARTON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN INVENTORY IT WAS NOTICED THAT THE DIAGNOSTIC ULTRASOUND CATHETER HAD "DAMAGED INTERIOR WRAPPING/PACKAGING." THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLI OEX STRYKER SUSTAINABILITY SOLUTIONS SNDSTR10G 175887SH

    Patients

    Seq Age Sex Outcome Treatment
    1