BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE B100L NG GREEN BULK AMG

    MDR report key: 9727545 · Received February 19, 2020

    Report

    Report Number
    3009081593-2020-00016
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    December 23, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8199966, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2018-07-18. MEDICAL DEVICE LOT #: 8180960, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2018-06-29. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: UNCONFIRMED, NO SAMPLE RECEIVED. INVESTIGATION CONCLUSION: THE CUSTOMER ISSUED A COMPLAINT FOR A DAMAGED/DEFECTIVE NEEDLE GUARD DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. ROOT CAUSE DESCRIPTION: THIS PRODUCT WAS DESIGNED WITH A LOW CLIPPING FORCE TO ACCOMMODATE EASILY ALL TYPES OF SYRINGES DURING DEVICE ASSEMBLY AND SO MINIMIZING RISK OF FLANGE OR DEVICE BREAKAGE. THE DRAW-BACK OF THIS DESIGN IS THE RELATIVELY LOW RETENTION FORCE. BASED ON INVESTIGATION CONCLUSION A SYRINGE CAN ONLY BECOME DETACHED IF SYRINGE CAPTURE FEATURES (HOLDING CLIPS) OF THE DEVICE OR THE FLANGE OF THE SYRINGE GET DAMAGED/BROKEN OR THE SYRINGE RECEIVES AN IMPACT AFTER SYRINGE INSERTION WHICH CAUSES IT TO UNCLIP FROM THE DEVICE. THE MANUAL NEEDLE GUARDS SYRINGE FLANGE HOLDING CLIPS WERE OBSERVED STRAIGHT AND PROPERLY ALIGNED. THE SYRINGE FLANGE AND BARREL WERE NOT CRACKED OR BROKEN. BASED ON THE DEFORMATION SEEN ON ONE OF THE HOLDING CLIPS THE SYRINGE WAS UNCLIPPED FROM THE DEVICE. THEREFORE, THE SYRINGE MOST LIKELY BECAME DETACHED AS IT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION. NONE OF THESE CAUSES ARE RELATED TO BD PROCESS. RATIONALE: COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE B100L NG GREEN BULK AMG SYRINGE SEPARATED FROM THE NEEDLE GUARD. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINANT REPORTED THAT THE TECHNICIAN HAD BEEN HOLDING THE PROLIA SYRINGE BY THE GREEN NEEDLE GUARD WHEN THE SYRINGE "SEPARATED" FROM THE NEEDLE GUARD AND THE SYRINGE FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194398 ULTRASAFE B100L NG GREEN BULK AMG ULTRASAFE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other