BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR NVS STEIN

    MDR report key: 8926500 · Received August 23, 2019

    Report

    Report Number
    3009081593-2019-00198
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    August 8, 2019
    Report Date
    September 9, 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

    H.6. INVESTIGATION SUMMARY: 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 THE INVESTIGATION CONCLUSION THE DEFECT OCCURRED DUE TO MISUSE OF THE COMBINATION PRODUCT. THE IDENTIFIED POTENTIAL CAUSES FOR PLUNGER PULLED OUT ISSUES ARE ALL RELATED TO MISUSE/MISHANDLING OF THE COMBINATION PRODUCT BY THE END USER. BD IFU WHICH WAS PROVIDED TO OUR CUSTOMER IS DETAILED ENOUGH TO AVOID MISHANDLING DURING REMOVAL OF THE COMBINATION PRODUCT FROM BLISTER OR DURING PREPARATION OF THE PRODUCT FOR ADMINISTRATION. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG CLEAR NVS STEIN EXPERIENCED STOPPER DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HE TOOK THE WRAP OFF THE SYRINGE AND WHEN HE WAS PREPARING TO STICK THE NEEDLE IN THE GREY PLUNGER PUSHED OUT AND THE MEDICATION SPURT OUT.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369, K122558. 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 THAT THE ULTRASAFE X100L PNG CLEAR NVS STEIN EXPERIENCED STOPPER DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HE TOOK THE WRAP OFF THE SYRINGE AND WHEN HE WAS PREPARING TO STICK THE NEEDLE IN THE GREY PLUNGER PUSHED OUT AND THE MEDICATION SPURT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721922 ULTRASAFE X100L PNG CLEAR NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 8128662

    Patients

    Seq Age Sex Outcome Treatment
    1 Other