BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2243072-2017-00209

    MDR report key: 6991795 · Received October 31, 2017

    Report

    Report Number
    2243072-2017-00209
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    June 10, 2016
    Report Date
    October 25, 2017
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE OR PHOTO 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. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SAFETY WAS ENGAGED ON A UNKNOWN BD VACUTAINER® WINGED SAFETY PUSH BUTTON BLOOD COLLECTION SET, BLOOD SPLATTERED CAUSING POSSIBLE EXPOSURE. NO INJURY OR MEDICAL INTERVENTION.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other