BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 7441000 · Received April 18, 2018

    Report

    Report Number
    3002682307-2018-00106
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 11, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: BD WAS NOT PROVIDED A PHOTO OR SAMPLE TO INVESTIGATE FOR THIS RECORD. AS A RESULT, BD CANNOT VERIFY THE REPORTED ISSUE. BHR REVIEW: 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 Nº2022 (JULY 26 - 27TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4238, AND Nº4204, IN LOT #7202263 (JULY 24 - 31ST, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7202246, AND #7198284 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7202247, #7187017, AND #7198290 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE ANALYSIS: WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. CONFIRMATION: NO SAMPLES AVAILABLE FOR EVALUATION. NO ISSUE FOUND IN THE BHR. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DURING USE OF THE DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WAS AN ISSUE WITH LEAKAGE. IT WAS STATED ¿THE MEDICINE LEAKS AT THE PISTON LEVEL WHEN INJECTING WITH THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283196 DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE WITHOUT NEEDLE FMF BECTON DICKINSON, S.A. 1707241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other