BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDEX INJECTION ADAPTER WITH MALE LUER LOCK

    MDR report key: 1861931 · Received October 4, 2010

    Report

    Report Number
    2183502-2010-00430
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 1, 2009
    Report Date
    October 1, 2010
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    PMA / PMN Number
    K944208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: REVIEW OF THE DEVICE HISTORY RECORD AND RELATED DOCUMENTS DID NOT SHOW ANY RELATED MFG ISSUES. INSPECTION AND TESTING INDICATED THAT THE DEVICE MET WITH REQUIREMENTS PRIOR TO RELEASE. THE ACTUAL DEVICE USED IN THE INCIDENT WAS NOT RETURNED. FIFTY SEVEN SAMPLE DEVICES WERE RETURNED FOR EVAL. ALL OF THE UNUSED DEVICES WERE FOUND TO BE IN FULLY INTACT, NO FAILURE WAS DETECTED AND THE PRODUCTS WERE WITHIN SPEC. THIRTY TWO OF THE RETURNED DEVICES WERE SELECTED AT RANDOM AND WERE BURST TESTED. ALL PASSED PERFORMANCE TESTING PER SPEC. NO FAILURE DETECTED AND RETURNED PRODUCT WITHIN SPEC. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    DURING A PROCEDURE THAT INVOLVED THE INJECTION OF A RADIOISOTOPE THE INJECTION ADAPTER WAS USED. THE INJECTION WAS HAND-INJECTED WITH A SYRINGE OF UNK SIZE. DURING THE PROCEDURE, THE DEVICE LEAKED WHICH ALLOWED EXPOSURE OF THE INFUSATE TO THE PT AND THE THERAPIST. NO REPORTED INTERVENTION OR MEDICAL SEQUELA FOR EITHER THE PT OR THE TECHNICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDEX INJECTION ADAPTER WITH MALE LUER LOCK FPA, SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. NA 1716288

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other