BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2464560 · Received February 22, 2012

    Report

    Report Number
    2090040-2012-00006
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Report Date
    January 27, 2012
    Product Code
    OEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. THE COMPLAINT DEVICE WAS RETURNED TO SSS IN ITS ORIGINAL SEALED PACKAGING. THE PACKAGE WAS NOTICED TO POSSESS INDENTIONS IN THE PROXIMITY OF THE DEVICE TIP. IT WAS CONFIRMED THAT THE STERILE BARRIER HAD BEEN BREACHED BY THE DEVICE TIP. IT WAS CONFIRMED THAT THESE DEVICES ARE SHIPPED FROM THE OM WITHOUT A TIP PROTECTOR; INSTEAD, THE DEVICE IS PACKAGED IN A POUCH CONFIGURATION THAT APPEARS TO PREVENT INDENTIONS IN THE PACKAGING WITHOUT THE USE OF A TIP PROTECTOR. THE PACKAGING WILL BE CHANGED TO USE THE SAME PACKAGING REQUIREMENTS CURRENTLY VALIDATED THROUGH THE FULL PROCESS TROCAR PRODUCT LINE IN SSS'S (B)(4) LOCATION. 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 WHILE IN INVENTORY AT THE USER FACILITY, IT WAS NOTICED THAT "THERE IS NO TIP PROTECTOR AND THE TROCAR IS PUNCTURING A HOLE IN THE PACKAGING." THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A GCJ OEX CB5LT

    Patients

    Seq Age Sex Outcome Treatment
    1