BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2317436 · Received November 1, 2011

    Report

    Report Number
    2090040-2011-00030
    Event Type
    Malfunction
    Date Received
    November 1, 2011
    Date of Event
    September 30, 2011
    Report Date
    October 6, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NLI
    PMA / PMN Number
    K092425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 WHICH WOULD INDICATE MISHANDLING. UPON OPENING THE OUTER BOX, THE INNER TYVEK POUCH WAS FOUND TO BE UNSEALED AT THE CHEVRON. THE SEAL WAS OTHERWISE INTACT AROUND THE PACKAGING. THE TYVEK POUCH WAS NOT TORN OR PUNCTURED. THE PACKAGING HAD BEEN PEELED OPEN AT THE SEAL AND THE RESIDUE ON THE MYLAR LOOKED LIKE THE SEAL WAS AT ONE POINT CONTIGUOUS. BASED ON THE RESULT OF THE INVESTIGATION, IT IS UNKNOWN AT WHAT POINT THE TYVEK POUCH WAS BREACHED. AS SEAL INTEGRITY IS VERIFIED AT EACH STATION PRIOR TO SECONDARY PACKAGING, WHERE THE DEVICE IS PACKAGED IN THE OUTER BOX, IT IS UNLIKELY THE BREACH OCCURRED PRIOR TO RELEASE FROM STRYKER. 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 THE INNER PACKAGE OF THE DIAGNOSTIC ULTRASOUND CATHETER WAS OPENED WHEN IT WAS HANDED TO THE SCRUB TECH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLI NLI STRYKER SUSTAINABILITY SOLUTIONS SNDSTR10 847955

    Patients

    Seq Age Sex Outcome Treatment
    1