BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LS DN EMERALD

    MDR report key: 12921059 · Received December 2, 2021

    Report

    Report Number
    3002682307-2021-00636
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    March 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903077434
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-03-21. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 30774319 AND LOT NUMBER 1905147. THE REVIEW ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY AND NO ABNORMALITIES OR QUALITY NOTIFICATIONS RELATED TO THIS REPORTED INCIDENT WERE IDENTIFIED. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO HUNDRED AND FORTY SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PROVIDED SAMPLES, NO DEFECTS COULD BE IDENTIFIED. TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE ALSO OBTAINED FOR EXAMINATION WITH NO DEFECTS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 5ML LS DN EMERALD, THE DEVICE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN PEDIATRICS, THE OUTER CASING OF THE SYRINGE IS TIGHT AND THE CORE ROD DOES NOT MATCH, SO THE SAMPLE CAN BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 5ML LS DN EMERALD, THE DEVICE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IN PEDIATRICS, THE OUTER CASING OF THE SYRINGE IS TIGHT AND THE CORE ROD DOES NOT MATCH, SO THE SAMPLE CAN BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817532 BD SYRINGE 5ML LS DN EMERALD PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1905147 00382903077434

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown