BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8412030 · Received March 12, 2019

    Report

    Report Number
    3002682307-2019-00187
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 3, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: 1803192: BD HAS 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 Nº2011 (MARCH 20TH ¿ 22ND, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #8067504 AND LOT #8050715. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8067999, #8043965, #8050847, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8075991, #8072883, #8065749, #8058730, #8050855, #8043964 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLES. BD HAS CARRIED OUT A LEAKAGE TEST AND DETERMINED THAT THE SAMPLES DID NOT PRESENT THE REPORTED DEFECT. BD COULD NOT CONFIRM THE REPORTED ISSUE. CONCLUSION(S): AFTER THE EVALUATION OF THE RECEIVED SAMPLE, BD COULD NOT DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. BD BELIEVES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR LEAKAGE OCCURRED PAST THE STOPPER OF THE BD¿ SYRINGE WITH NEEDLE DURING USE, PREVENTING MEDICATION FROM BEING PUSHED OUT OR DRAWN UP. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM CHINESE TO ENGLISH, "DURING USING, IT WAS FOUND AIR LEAKED FORM PLUNGER AND CAN'T TAKING SOLUTION."

    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 THAT AIR LEAKAGE OCCURRED PAST THE STOPPER OF THE BD¿ SYRINGE WITH NEEDLE DURING USE, PREVENTING MEDICATION FROM BEING PUSHED OUT OR DRAWN UP. AS REPORTED BY THE CUSTOMER, TRANSLATED FROM CHINESE TO ENGLISH, "DURING USING, IT WAS FOUND AIR LEAKED FORM PLUNGER AND CAN'T TAKING SOLUTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208325 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1803192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other