BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOSHOT¿ MINI AUTO-DISABLE SYRINGE

    MDR report key: 8142513 · Received December 7, 2018

    Report

    Report Number
    3002682307-2018-00323
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 3, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE 2019 (JUNE 23-25TH, 2017) DURING WHICH 59 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECT NOTED. BARRELS WERE MARKED (#7170475) IN MACHINE #4257 (JUNE 20-27TH, 2017) DURING WHICH 140 VISUAL INSPECTIONS WERE PERFORMED WITHOUT OBSERVING ISSUES OR ABNORMALITIES. BASED ON DESCRIPTION OF THE ISSUE, BD UNDERSTANDS A DEFECTIVE MARKING IS OBSERVED WHICH PROVOKE THE ¿INABILITY TO WITHDRAW THE EXACT AMOUNT OF VACCINE.¿ SINCE NO SAMPLE OR PICTURE HAVE BEEN PROVIDED AND REVIEW OF DHR SHOW NO ABNORMALITIES OR ISSUES DURING MARKING STEP, DEFECT IS NOT CONFIRMED AND IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE RELATED SYRINGE MANUFACTURING PROCESS, AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SOLOSHOT¿ MINI AUTO-DISABLE SYRINGE THERE WAS AN ISSUE WITH INABILITY TO WITHDRAW EXACT AMOUNT OF VACCINE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 WITH THE USE OF THE BD SOLOSHOT¿ MINI AUTO-DISABLE SYRINGE THERE WAS AN ISSUE WITH INABILITY TO WITHDRAW EXACT AMOUNT OF VACCINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982272 BD SOLOSHOT¿ MINI AUTO-DISABLE SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1706560

    Patients

    Seq Age Sex Outcome Treatment
    1 Other