BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2243072-2017-00197

    MDR report key: 6989158 · Received October 30, 2017

    Report

    Report Number
    2243072-2017-00197
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    September 16, 2017
    Report Date
    October 13, 2017
    PMA / PMN Number
    K980414
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE 23 G X 0.75 IN NEEDLE X 12 IN TUBING BD SAFETY-LOK¿ BLOOD COLLECTION AND INFUSION SET WITH LUER ADAPTER, THE GRAY RUBBER SLEEVE ISN'T CLOSING OVER THE END OF THE NEEDLE THAT GOES INTO THE VACUTAINERS CAUSING BLOOD TO LEAK. THERE IS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other