BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 X 0.75 IN. NEEDLE X 12 IN TUBING BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET

    MDR report key: 6174274 · Received December 14, 2016

    Report

    Report Number
    1024879-2016-00065
    Event Type
    Malfunction
    Date Received
    December 14, 2016
    Date of Event
    November 23, 2016
    Report Date
    January 16, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DEVICE MANUFACTURE DATE WAS INITIALLY REPORTED AS 6/2/2016. IT HAS BEEN CORRECTED TO THE FOLLOWING: DEVICE MANUFACTURE DATE: 5/19/2016. DEVICE EVALUATION: RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE SUSPECT DEVICE WAS MANUFACTURED IN MAY, 2016 AND NO IRREGULARITIES WERE DISCOVERED DURING THE MANUFACTURE OF THE REPORTED LOT # 6140635. 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 AS A PHLEBOTOMIST WAS OPENING THE PACKAGE OF A 23 X 0.75 IN. NEEDLE X 12 IN TUBING BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET, HE/SHE OBTAINED A NEEDLE STICK INJURY BECAUSE THE NEEDLE COVER HAD SEPARATED FROM THE NEEDLE AND WAS LOOSE IN THE PACKAGE. THERE WAS NO REPORT OF MEDICAL INTERVENTIONS FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825286 23 X 0.75 IN. NEEDLE X 12 IN TUBING BD SAFETY-LOK¿ BLOOD COLLECTION WINGSET BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 6140635

    Patients

    Seq Age Sex Outcome Treatment
    1 Other