BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 10 ML SYRINGE

    MDR report key: 11882152 · Received May 25, 2021

    Report

    Report Number
    3002682307-2021-00208
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2012217 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF DEFECT WERE DETECTED. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II 10 ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A QUALITY DEFECT WAS OBSERVED ON A BD DISCARDIT 10ML SYRINGE REF 309110, THE NURSE WHO USED THE SYRINGE REPORTED TO ME THAT IT WAS LEAKING AT THE PLUNGER, BATCH 2012217. THE INCIDENT IS ISOLATED AND WITHOUT CONSEQUENCE.

    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 THAT THE BD DISCARDIT¿ II 10 ML SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A QUALITY DEFECT WAS OBSERVED ON A BD DISCARDIT 10ML SYRINGE REF 309110, THE NURSE WHO USED THE SYRINGE REPORTED TO ME THAT IT WAS LEAKING AT THE PLUNGER, BATCH 2012217. THE INCIDENT IS ISOLATED AND WITHOUT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771844 BD DISCARDIT II 10 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2012217

    Patients

    Seq Age Sex Outcome Treatment
    1