BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGIST TRAY WITH BD SAFETYGLIDE¿

    MDR report key: 7260878 · Received February 9, 2018

    Report

    Report Number
    1920898-2018-00031
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 16, 2018
    Report Date
    March 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SEVERITY: S2; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE UNKNOWN RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLESTICK WITH LOT #7171628 REGARDING ITEM #305950 INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1ML, 13MM, 27G BD SAFETYGLIDE ALLERGY SYRINGES FROM LOT # 7171628. CUSTOMER STATES THAT THE RN ACTIVATED THE SAFETY DEVICE AFTER GIVING AN INJECTION AND THAT PIECE CAME OFF THE SYRINGE AND FLIPPED AND LANDED ON HER FOREARM. THE PHOTOS WERE EXAMINED AND EXHIBITED THE HUB-NEEDLE/SAFETY MECHANISM ASSEMBLY SEPARATED FROM THE BARREL. SINCE THE ASSEMBLY SEPARATED FROM THE BARREL WITHOUT PROPERLY COVERING THE CANNULA TIP, A NEEDLE STICK COULD OCCUR. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE, THEREFORE NO DEVICE HISTORY RECORD REVIEW IS NECESSARY. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES FOR HUB SEPARATES ISSUE INCLUDE: BROKEN PLUNGER LODGED IN BETWEEN BARREL AND SHIELD CARRIERS MAY CAUSE INCOMPLETE SHIELD ASSEMBLIES. SYSTEMS WITH PLUNGER SCREW IN FEEDS HAVE A GREATER PROPENSITY FOR CREATING BROKEN PLUNGERS VERSUS MACHINES WITH DIAL IN FEEDS. A MISALIGNED LASER SENSOR (RAISED SHIELD) FROM ITS DESIGNATED DETECTING POSITION MAY RESULT IN SENDING DEFECTIVE PARTS WITH GATE FLASH AND/OR RAISED NEEDLE ASSEMBLIES TO PACKAGING AS GOOD PRODUCT. HUB CORE DAMAGE (EITHER FROM SEATING ON RACKS OR DURING ASSEMBLY ONTO BARREL), ADHESIVE RUN-OVER CAUSING EXCESSIVE FORCE REQUIRED TO REMOVE SHIELD, DISASSEMBLING HUB FROM THE SYRINGE. CAPA (B)(4) HAS BEEN OPENED TO ADDRESS THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INCORRECT DATE: DATE RECEIVED BY MANUFACTURER: 07/31/2022. SHOULD BE DATE RECEIVED BY MANUFACTURER: 01/17/2018.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT WHEN ACTIVATING THE SAFETY RETRACTION FEATURE OF THE ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE, THE NEEDLE DETACHED FROM THE DEVICE, FLIPPED AND LANDED ON HER FOREARM. A NEEDLE STICK INJURY DID OCCUR HOWEVER, NO REPORTS OF INTERVENTION WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102886 ALLERGIST TRAY WITH BD SAFETYGLIDE¿ SAFETY ENGINEERED HYPODERMIC NEEDLE MEG BD MEDICAL - DIABETES CARE 7171628 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other