BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITONEAL INTRODUCER SHEATHS 70CM

    MDR report key: 5988769 · Received September 29, 2016

    Report

    Report Number
    9612007-2016-00038
    Event Type
    Malfunction
    Date Received
    September 29, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 29, 2016
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GYK
    PMA / PMN Number
    K771529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 14NOV2016. THE INVESTIGATION INCLUDED: METHOD: - REVIEW OF DEVICE HISTORY RECORDS. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: THE DEVICE HISTORY RECORDS OF REF 9MD170 LOT 195056 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN APRIL 2016 AND INCLUDED (B)(4) PRODUCTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. THE REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE SINCE 2013 FOR 9MD170 REVEALED NO SIMILAR COMPLAINT. (B)(4). A REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE FOR ALL OTHER BIOT PRODUCTS SINCE 2013 REVEALED TWO SIMILAR SHIPPING ISSUES. CONCLUSION: NO PRODUCT WAS RECEIVED; THE COMPLAINT IS UNVERIFIABLE. THE MOST LIKELY CAUSE IS A DAMAGE DURING THE SHIPMENT TO THE HOSPITAL.

    Description of Event or Problem · 1

    PACKAGE WAS RECEIVED INTACT BUT WHEN IT WAS OPENED, THE PRODUCT PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 09AUG2016: THE PRODUCT PROBLEM WAS DISCOVERED WHEN IT WAS DELIVERED. THE BOX THAT HOLDS THE PRODUCT WAS BENT IN AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640656 PERITONEAL INTRODUCER SHEATHS 70CM VALVE ACCESSORIES GYK INTEGRA NEUROSCICENCS IMPLANTS SA 0195056

    Patients

    Seq Age Sex Outcome Treatment
    1