BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19G X 50MM BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 6350562 · Received February 22, 2017

    Report

    Report Number
    3002682307-2017-00002
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 21, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. DEVICE MANUFACTURE DATE: MAY, 2016. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 160518. 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. HOWEVER, ALTHOUGH THE DHR REVIEW FOUND NO ABNORMALITIES DURING THE PRODUCTION PROCESS, OUR QUALITY ENGINEER NOTES THAT A POTENTIAL CAUSE FOR THIS INCIDENT COULD BE A COMBINATION OF TWO FACTORS; THE LOWEST RANGE IN THE FITTING FORCE BETWEEN THE HUB AND SHIELD AND ISSUES IN THE PRIMARY PACKAGING FEEDER WHICH MAY RESULT IN A LOOSE NEEDLE SHIELD. TO AVOID THIS SITUATION, THERE IS A NEEDLE LENGTH DETECTOR REJECTING THOSE THAT DO NOT REACH THE SPECIFIED DISTANCE. IN THIS CASE, THE NEEDLE MAY HAVE AVOIDED THE PREVENTIVE SYSTEMS AND WAS PACKAGED NORMALLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS AN ODP WAS OPENING THE PACKAGE OF A 19G X 50MM BD MICROLANCE¿ HYPODERMIC NEEDLE, THERE WAS NOT A SHIELD ON THE NEEDLE AND THE ODP SUFFERED A CLEAN NEEDLE STICK INJURY. THE ODP WAS PROVIDED ROUTINE FIRST AID BUT THERE WAS NO REPORT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133710 19G X 50MM BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 160518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other