BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE WITH DETACHED NEEDLE

    MDR report key: 8035069 · Received November 2, 2018

    Report

    Report Number
    3002682307-2018-00264
    Event Type
    Malfunction
    Date Received
    November 2, 2018
    Date of Event
    October 16, 2018
    Report Date
    December 4, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PICTURE AVAILABLE FOR EVALUATION. DHR REVIEW ON LOT NUMBER 1702605: 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 Nº2017 (JANUARY 30TH ¿ FEBRUARY 2ND, 2017). NEEDLES WERE ASSEMBLED IN MACHINE, Nº4213, IN LOT #7020371 (JANUARY 24TH ¿ 31ST, 2017) AND IN LOT #7031200 (JANUARY 31ST ¿ FEBRUARY 7TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. SYRINGES WERE ASSEMBLED IN LOT #8022706. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE HUB LOTS #7031207, #7024059, #7016141, #6356197, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE CANNULA LOTS #6323250, AND #6344460 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. IT WAS NOT POSSIBLE TO ESTABLISH AN ACCURATE ROOT CAUSE. POSSIBLE HANDLING OF THE PRODUCT OR INTERACTION WITH MEDICATION COULD PRODUCE THE REPORTED ISSUES. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD EMERALD¿ SYRINGE WITH DETACHED NEEDLE THERE WAS AN ISSUE WITH DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 EMERALD¿ SYRINGE WITH DETACHED NEEDLE THERE WAS AN ISSUE WITH DIFFICULT PLUNGER MOVEMENT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875513 BD EMERALD¿ SYRINGE WITH DETACHED NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1702605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other