BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    MDR report key: 7060491 · Received November 27, 2017

    Report

    Report Number
    2647876-2017-00002
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    November 2, 2017
    Report Date
    December 1, 2017
    Manufacturer
    BD CARIBE, LTD
    Product Code
    GMQ
    UDI-DI
    30382902703090
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINED OF SPLASH IN THEIR EYES. NO LABORATORY TEST CAN BE PERFORMED SINCE LOT NUMBER IS UNKNOWN. THE COMPLAINT HISTORY FILE FOR THIS PRODUCT WAS VERIFIED AND NO OTHER COMPLAINT WERE RECEIVED WITH THIS CUSTOMER CLAIM. SAFETY DATA SHEET WAS VERIFIED AND IT CONTAINS FIRST AID MEASURES FOR EYE CONTACT. ¿AFTER EYE CONTACT, RINSE OPENED EYE FOR 15 MINUTES UNDER RUNNING WATER. THEN CONSULT YOUR DOCTOR¿. PRODUCT INSERT HAS WARNING NOTICE IN CASE PRODUCT BE IN CONTACT WITH THE EYES. ALTHOUGH LOT NUMBER WAS NOT PROVIDED BY CUSTOMER, DROP TEST OF THE LAST LOT OF NEEDLE RECEIVED IN HOUSE WAS VERIFIED. SATISFACTORY RESULTS WERE OBTAIN WHEN DROP TEST WAS PERFORMED. THE COMPLAINT WAS UNCONFIRMED BY BD SERVICE PERSONNEL. ROOT CAUSE UNKNOWN, LOT NUMBER WAS NOT PROVIDED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION, THE ANTIGEN SPLASHED IN THE EYES OF THE OPERATOR DURING USE. MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839363 BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION RPR ANTIGEN GMQ BD CARIBE, LTD UNKNOWN 30382902703090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention