BEUDAMED
    FDA Adverse Event Injury Summary report: N

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6372372 · Received March 2, 2017

    Report

    Report Number
    8041187-2017-00015
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    December 3, 2016
    Report Date
    March 2, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI AND FMF. (B)(4). RESULTS: A SAMPLE 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. 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. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLINICIAN SUFFERED A CONTAMINATED NEEDLE STICK INJURY AFTER PATIENT USE WHILE USING A 27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE. IT IS UNKNOWN IF A SAFETY MECHANISM FAILURE LED TO THE INJURY. THE CLINICIAN RECEIVED POST EXPOSURE LAB WORK AND SIX DAYS OF POST EXPOSURE PROPHYLAXIS. THE CLINICIAN ALSO RECEIVED FOLLOW UP LAB WORK AT 6 WEEKS AND 12 WEEKS POST INJURY AND WILL RECEIVE ADDITIONAL FOLLOW UP LAB WORK AT 6 MONTHS POST INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157576 27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention