BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6445020 · Received March 29, 2017

    Report

    Report Number
    1213809-2017-00020
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    March 6, 2017
    Report Date
    May 22, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THE NEEDLE HAD RETRACTED INTO THE SYRINGE BARREL. THERE WAS NO NEEDLE DETACHMENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4002414. CONCLUSION: 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.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE FROM A 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE FAILED TO RETRACT AND BROKE OFF AS A CONSUMER INJECTED HIS BUTTOCKS. THE CONSUMER TOOK THE SYRINGE TO HIS PHARMACIST WHO TOOK APART THE SYRINGE AND SAW THE SPRING BUT DID NOT SEE THE NEEDLE. THE CONSUMER WENT TO AN EMERGENCY DEPARTMENT AS RECOMMENDED BY THE PHARMACIST BUT DECLINED X-RAYS AND THE PROCEDURE TO REMOVE THE BROKEN NEEDLE AFTER HE WAS QUOTED THE PRICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225246 23 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 4002414

    Patients

    Seq Age Sex Outcome Treatment
    1 Other