BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEATH PERITONEAL 61CM (24IN) - BOX OF 5

    MDR report key: 2002289 · Received January 25, 2011

    Report

    Report Number
    9612007-2011-00004
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Report Date
    January 26, 2011
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Removal / Correction Number
    RECALL OF SHEATH PERITON
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED INFO AND INVESTIGATION OF THE RETURNED PRODUCT, THE REPORTED CONDITION WAS CONFIRMED. IT WAS CONCLUDED THAT IT WAS DUE TO A MFG ERROR DURING PACKAGING. A RECALL HAS BEEN INITIATED AND CORRECTIVE ACTIONS ARE BEING IMPLEMENTED TO PREVENT RECURRENCE OF SUCH ERROR. INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    AFTER A RETROSPECTIVE REVIEW OF THIS COMPLAINT, A DECISION WAS MADE TO SUBMIT THIS COMPLAINT AS A MEDICAL DEVICE REPORT (MDR). THE BOXES OF PERITONEAL SHEATHS THAT WERE RECEIVED BY THE CUSTOMER WERE LABELED AS 24 INCHES IN LENGTH. HOWEVER, THE PERITONEAL SHEATHS INSIDE THE BOXES WERE 18 INCHES IN LENGTH. THERE WAS NO PT CONTACT OR PT INJURY. ADD'L CLINICAL INFO HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHEATH PERITONEAL 61CM (24IN) - BOX OF 5 CSF PRODUCTS JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 0162956

    Patients

    Seq Age Sex Outcome Treatment
    1