BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 9916071 · Received April 2, 2020

    Report

    Report Number
    3002682307-2020-00119
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 10, 2020
    Report Date
    April 6, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: AS A SAMPLE WAS NOT AVAILABLE FOR RETURN, OUR QUALITY TEAM WAS UNABLE TO CONDUCT A THOROUGH SAMPLE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1912116. THE REVIEW REVEALED ONE RELATED QUALITY NOTIFICATION DURING THE PRODUCTION PROCESS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. DURING THE PRODUCTION PROCESS DAMAGE TO THE PLUNGER LIP WAS OBSERVED, AND THE PRODUCTION PROCESS WAS HELD FOR SEGREGATION OF FAULTY PRODUCT. THIS INCIDENT RESULTED DUE TO INCORRECT SEGREGATION OF FAULTY PRODUCT BY THE OPERATOR. WE ARE CONFIDENT THAT THIS IS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE, THEREFORE, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE LEAKED "NACL" PAST THE PLUNGER DURING USE WHILE "SOLUPRED" WAS BEING RECONSTITUTED IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WHEN RECONSTITUTING A DRUG (SOLUPRED, POWDER TO BE RECONSTITUTED) IN A 10 ML SYRINGE, LEAKAGE OF THE RECONSTITUTION (NACL) AT THE PLUNGER OF THE SYRINGE."

    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 THE BD DISCARDIT¿ II SYRINGE LEAKED "NACL" PAST THE PLUNGER DURING USE WHILE "SOLUPRED" WAS BEING RECONSTITUTED IN IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN RECONSTITUTING A DRUG (SOLUPRED, POWDER TO BE RECONSTITUTED) IN A 10 ML SYRINGE, LEAKAGE OF THE RECONSTITUTION (NACL) AT THE PLUNGER OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382695 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1912116

    Patients

    Seq Age Sex Outcome Treatment
    1 Other