BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG RASPBERRY NVS STEIN

    MDR report key: 9312143 · Received November 12, 2019

    Report

    Report Number
    3009081593-2019-00252
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 24, 2019
    Report Date
    December 19, 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 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. TESTS PERFORMED BY BD TATABÁNYA DURING PRODUCTION CONTROLS ARE RELATED TO THE ASSEMBLED DEVICE, WITHOUT USING SYRINGE AND PLUNGER ROD. TESTING OF COMBINATION PRODUCT IS OUT OF SCOPE FOR SAFETY DEVICE MANUFACTURING. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE OF THE ULTRASAFE X100L PNG RASPBERRY NVS STEIN THE NEEDLE DID NOT RETRACT AFTER THE INJECTION WAS GIVEN. THE SAFETY DEVICE DID NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER MEDICAL ASSISTANT: THE NEEDLE DID NOT RETRACT AFTER THE INJECTION WAS GIVEN." SAFETY DEVICE DID NOT ACTIVATE.

    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 #: 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 WAS REPORTED THAT AFTER USE OF THE ULTRASAFE X100L PNG RASPBERRY NVS STEIN THE NEEDLE DID NOT RETRACT AFTER THE INJECTION WAS GIVEN. THE SAFETY DEVICE DID NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AS PER MEDICAL ASSISTANT: THE NEEDLE DID NOT RETRACT AFTER THE INJECTION WAS GIVEN." SAFETY DEVICE DID NOT ACTIVATE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103458 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