BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2379654 · Received December 16, 2011

    Report

    Report Number
    2090040-2011-00037
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Report Date
    November 23, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLI
    PMA / PMN Number
    K063076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR EVALUATION. THE DEVICE BOX POSSESSED VISIBLE DAMAGE AT APPROXIMATELY 13 INCHES FROM THE PROXIMAL END OF THE BOX. THE DAMAGE POSSESSED A GREEN RESIDUE AT THE SITE OF IMPACT. THE DAMAGE PENETRATED THE OUTER BOX AND THE TYVEK POUCH CAUSING A STERILITY BREACH. OTHER NOTABLE DAMAGE WAS LOCATED ALONG THE MID-SECTION OF THE BOX. THE MATERIAL WAS BENT AND THE INNER TRAY WAS CRUSHED FORM WHAT APPEARED TO BE SIDE IMPACT. THE STERILE BARRIER WAS NOT COMPROMISED AT THIS SITE. BASED ON THE MANNER OF THE PACKAGING, THE DAMAGE WOULD HAVE OCCURRED AFTER BOXING SINCE THE INNER AND OUTER DAMAGE MATCH IN DIMENSION AND LOCATION. THE TYVEK PACKAGING INDICATES THE IMPACTING SOURCE MAY HAVE BEEN SHARP WHILE THE BOX INDICATES IT MAY HAVE ALSO POSSESSED A GREEN RESIDUE. A REVIEW OF THE IN-HOUSE STORAGE AND TRANSFER EQUIPMENT FOR BOXING AND FINISHED GOODS INDICATES NO LIKELY SOURCE OF THE DAMAGE. THERE IS ALSO NO EQUIPMENT CONTAINING SHARP OR GREEN COMPONENTS THAT WOULD HAVE CONTRIBUTED TO THE CAUSE OF THIS DAMAGE. THE FACILITY DID NOT REPORT THAT THE SHIPPING BOX HAD ANY DAMAGE WHICH INDICATES THE DAMAGE DID NOT LIKELY OCCUR DURING SHIPPING OR TRANSIT. THIS SUGGESTS THE DAMAGE OCCURRED AFTER DISTRIBUTION FROM SSS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE ULTRASOUND CATHETER WAS RECEIVED AT THE USER FACILITY, IT WAS NOTED THAT THE BOX HAD A CUT IN IT. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLI NLI STRYKER SUSTAINABILITY SOLUTIONS 10135936

    Patients

    Seq Age Sex Outcome Treatment
    1