BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRRIGATION TUBING AND CLIPS

    MDR report key: 2980129 · Received February 21, 2013

    Report

    Report Number
    1045834-2013-00302
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THERE WAS "FOREIGN DEBRIS IN THE STERILE PACKAGE" DISCOVERED DURING INCOMING INSPECTION. THE DEVICE WAS NOT USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75533 IRRIGATION TUBING AND CLIPS HBC THE ANSPACH EFFORT, INC. MBHK320

    Patients

    Seq Age Sex Outcome Treatment
    1