BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE

    MDR report key: 4146703 · Received October 7, 2014

    Report

    Report Number
    2210968-2014-14303
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THERE WERE MULTIPLE SCRATCH MARKS ON THE PACKAGE. THE DEVICE POSITION AND PAPER FOLDER CONDITION INDICATES THAT THE DEVICE WAS MISHANDLED AT UNKNOWN POINT AND CANNULA AND PAPER FOLDER IMPACTED THE SEAL AREA, THEREFORE STERILE BARRIER WAS COMPROMISED AS A RESULT OF A SEVERE NON-NORMAL HANDLING AFTER IT WAS SHIPPED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE STRAPS WERE USED. PRIOR TO USING THE DEVICE ON THE PATIENT, IT WAS NOTICED THAT THE FOIL PACKAGING WAS NOT SEALED PROPERLY AND THE TIP OF THE DEVICE WAS OUTSIDE THE PACKAGING. THE DEVICE WAS NOT USED BECAUSE IT WAS NOT STERILE. THE PROCEDURE WAS COMPLETED WITH A SAME LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629597 SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE STAPLE, IMPLANTABLE GDW ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1