BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2243072-2017-00228

    MDR report key: 7075843 · Received December 1, 2017

    Report

    Report Number
    2243072-2017-00228
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    October 28, 2015
    Report Date
    November 3, 2017
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. RESULTS: 3 CUSTOMER SAMPLES WERE RETURNED. THEY WERE CHECKED VISUALLY AND NO DEFECT WAS SEEN ON ANY PART. FUNCTION OF THE RELEASE WAS CHECKED WITH A NORMAL ACTION FORCE BY THE FINGERS AND IT WAS CONFIRMED IT WORKED NORMALLY. A BD BLOOD COLLECTION NEEDLE WAS CONNECTED. THE NEEDLE WAS NOT LOOSE AND COULD BE REMOVED SMOOTHLY. THE SAME CHECKS WERE DONE ON 10 RETAINED LOT SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 13F10. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE WAS STUCK IN A BD VACUTAINER¿ PRONTO¿ QUICK RELEASE NEEDLE HOLDER BECAUSE ITS BUTTON WOULD NOT ACTIVATE. THE USER HIT THE APPARATUS ON A TABLE TO DISLODGE THE NEEDLE. DIRTY NEEDLE STICK. MEDICAL INTERVENTION UNKNOWN.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other