BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG TEAL NVS STEIN

    MDR report key: 10640189 · Received October 7, 2020

    Report

    Report Number
    3009081593-2020-00095
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 9, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. BASED ON INVESTIGATION CONCLUSION A SYRINGE CAN ONLY BECOME DETACHED IF SYRINGE CAPTURE FEATURES OR THE FLANGE OF THE SYRINGE GET DAMAGED/BROKEN OR IF THE SYRINGE RECEIVES AN IMPACT AFTER SYRINGE INSERTION WHICH CAUSES IT TO UNCLIP FROM THE DEVICE. THEREFORE, THE SYRINGE MOST LIKELY BECAME DETACHED AS IT WAS NOT CLIPPED INTO THE DEVICE PROPERLY OR IT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION WHICH CAUSED IT TO UNCLIP FROM THE DEVICE. NONE OF THESE CAUSES ARE RELATED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ULTRASAFE X100L PNG TEAL NVS STEIN EXPERIENCED SAFETY DEVICE SEPARATION/DAMAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE DETACHED FROM NEEDLE SAFETY DEVICE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8114896, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 , DEVICE MANUFACTURE DATE: 2018-04-24. MEDICAL DEVICE LOT #: 8111615, MEDICAL DEVICE EXPIRATION DATE: 2023-03-31 , DEVICE MANUFACTURE DATE: 2018-04-21. PMA/510(K)#: AN ADDITIONAL PMA/510(K) # IS LISTED AS: K122558. DEVICE EVALUATED BY MFR: 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 AN UNSPECIFIED NUMBER OF ULTRASAFE X100L PNG TEAL NVS STEIN EXPERIENCED SAFETY DEVICE SEPARATION/DAMAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE DETACHED FROM NEEDLE SAFETY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104849 ULTRASAFE X100L PNG TEAL NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other