BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6538989 · Received May 2, 2017

    Report

    Report Number
    1213809-2017-00025
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    April 12, 2017
    Report Date
    June 5, 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
    FL, US
    Reporter Occupation
    PATIENT

    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

    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 # 4202862. 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 A NEEDLE OF A 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE INADVERTENTLY RETRACTED DURING USE AND A CONSUMER THOUGHT IT BROKE OFF IN HER INJECTION SITE. THE CONSUMER WENT TO A HOSPITAL AND RECEIVED AN X-RAY, BUT LATER THE NEEDLE WAS DISCOVERED INSIDE OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320743 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 4202862

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention