BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ML ALLERGIST TRAY W/ 27GX1/2IN. BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE

    MDR report key: 6136121 · Received November 30, 2016

    Report

    Report Number
    1920898-2016-00045
    Event Type
    Injury
    Date Received
    November 30, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 14, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL/MICROSCOPIC INSPECTION REVEALED THE NEEDLE WAS BENT AND BROKEN OFF OF THE SYRINGE. A HOLE IN THE NEEDLE SHIELD WAS ALSO OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6062969. CONCLUSION: ALTHOUGH A VISUAL/MICROSCOPIC INSPECTION CONFIRMED THE CUSTOMER'S INDICATED FAILURE MODE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE FOLLOWING INFORMATION REGARDING A 1 ML ALLERGIST TRAY WITH 27 G X 1/2 IN. BD PRECISION GLIDE¿ PERMANENTLY ATTACHED NEEDLES: "I PULLED THE NEEDLE FROM THE TRAY WITH MY RIGHT (HOLDING THE BARREL) MY LEFT HAND WAS GOING TO PULL THE GRAY CAP OFF AS I DID I FELT A SHARP OBJECT STRIKE MY LEFT MID INDEX FINGER. UPON INSPECTION I SAW BLOOD COMING FROM MY FINGER. FURTHER EXAM REVEALED THAT THE NEEDLE WAS PROTRUDING CLEAR THROUGH THE SYRINGE CAP, BENT AND CLEARLY NOT ATTACHED TO THE HUB OF THE NEEDLE. THE NEEDLE LOOKED LIKE A FISHING HOOK." THE CUSTOMER RECEIVED LAB WORK ((B)(6) PANEL) PER HER HIS/HER FACILITY'S NEEDLE STICK PROTOCOL AND WILL HAVE LABS DRAWN EVERY THREE MONTHS FOR ONE YEAR. THE NEXT LAB DRAW IS ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786441 1ML ALLERGIST TRAY W/ 27GX1/2IN. BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE ALLERGY SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6062969

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention