BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL PURPOSE CATHETER

    MDR report key: 2851027 · Received November 21, 2012

    Report

    Report Number
    1036710-2012-00011
    Event Type
    Other
    Date Received
    November 21, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    DQO
    PMA / PMN Number
    R544937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE COMPLAINT HAS DETERMINED THAT MIXED CATHETER WERE RECEIVED FROM THE VENDOR. THE VENDOR HAS BEEN NOTIFIED. TO PREVENT FUTURE OCCURRENCES, THE INSPECTION REQUIREMENTS HAVE BEEN UPDATED TO INCLUDE SIZE VERIFICATION. A HEALTH HAZARD ANALYSIS HAS BEEN COMPLETED TO REVIEW AND PATIENT RISK OF THE DEVICES IN THE FIELD, AND DEEMED NO PATIENT RISK. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    ORDER WAS FOR P/N 756516025, LOT #21302BZH - 16F CATHETER. THE INCORRECT CATHETER WAS INSIDE THE PACKAGING. THEY RECEIVED A 12F CATHETER INSIDE THE PACKAGING FOR THE 16F. THE DEVICE WAS USED ON THE PATIENT, BUT THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL PURPOSE CATHETER SKATER ALL PURPOSE CATHETER DQO ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 756516025 21302BZH

    Patients

    Seq Age Sex Outcome Treatment
    1