BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE 27 G X 19 MM

    MDR report key: 6566763 · Received May 15, 2017

    Report

    Report Number
    3002682307-2017-00008
    Event Type
    Injury
    Date Received
    May 15, 2017
    Date of Event
    April 25, 2017
    Report Date
    May 12, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. RETENTION SAMPLES WERE EVALUATED AND SHOWED NO INDICATION OF THE ALLEGED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 160922. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD MICROLANCE¿ HYPODERMIC NEEDLE 27 G X 19 MM BROKE OFF IN A PATIENT'S LEG DURING AN INJECTION. THE HOSPITAL HAS ATTEMPTED THREE TIMES TO REMOVE THE NEEDLE VIA SURGERY BUT HAS BEEN UNSUCCESSFUL. NO FURTHER DETAILS ABOUT ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347847 BD MICROLANCE¿ HYPODERMIC NEEDLE 27 G X 19 MM HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 160922

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention