BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG RASPBERRY NVS STEIN

    MDR report key: 9251923 · Received October 29, 2019

    Report

    Report Number
    3009081593-2019-00239
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 14, 2019
    Report Date
    November 5, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NEITHER PHOTO NOR SAMPLE 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE ULTRASAFE X100L PNG RASPBERRY NVS STEIN HAS BEEN FOUND DEFORMED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DEFECT CATEGORY: SYRINGE DETACHED FROM NSD. FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN DESCRIBED 150 MG XOLAIR PFS NEEDLE AND SPRING CAME APART WAS ABLE PUT BACK TOGETHER AND ADMINISTER PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8071890. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-12. MEDICAL DEVICE LOT #: 8068790. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-09. PMA/510(K)#: K011369 / K122558. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE ULTRASAFE X100L PNG RASPBERRY NVS STEIN HAS BEEN FOUND DEFORMED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DEFECT CATEGORY: SYRINGE DETACHED FROM NSD. FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN DESCRIBED 150 MG XOLAIR PFS NEEDLE, AND SPRING CAME APART WAS ABLE PUT BACK TOGETHER, AND ADMINISTER PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048168 ULTRASAFE X100L PNG RASPBERRY NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other