BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6276913 · Received January 25, 2017

    Report

    Report Number
    1213809-2017-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 17, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). DEVICE MANUFACTURE DATE: 04/06/2016 TO 04/11/2016. DEVICE EVALUATION: RESULT - THE BD COMPLAINT HANDLING LAB RECEIVED TWO (2) BD 25 GAX 5/8IN 3ML INTEGRA SYRINGE WITH NEEDLE CAT# 305269 LOT# 6081867. ONE (1) SAMPLE WAS SEALED AND THE OTHER SAMPLE WAS RETURNED LOOSE AND WITHOUT PACKAGING. THE SAMPLES WERE VISUALLY INSPECTED AND OBSERVED. THE ONE (1) SEALED SAMPLE HAD NO DEFECTS OR ISSUES. ON THE OTHER SAMPLE THAT WAS RECEIVED LOOSE, THE TOP OF THE SHIELD WAS BROKEN OFF AND NEEDLE WAS EXPOSED. THIS IS WHAT CAUSED THE NEEDLE STICK INJURY. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 6081867. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP OF THE SUSPECT DEVICE WAS DEFECTIVE. WHEN THE EMPLOYEE TWISTED THE CAP ON THE SYRINGE PRIOR TO USE, THE TIP CAME APART/BROKE AND SHE POKED HER THUMB. NO INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60984 25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 6081867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other