BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 16261203 · Received January 28, 2023

    Report

    Report Number
    3002682307-2023-00005
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    December 22, 2022
    Report Date
    February 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2211205. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION; HOWEVER, THE RETAINED SAMPLES DID NOT SHOW ANY SIGNS OF LEAKAGE. IT HAS BEEN CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE RESULTED FROM DAMAGE TO PLUNGER COMPONENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BACK OF THE BD DISCARDIT¿ II SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE MEDICATION RUNS OUT OF THE BACK OF THE CONE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE BACK OF THE BD DISCARDIT¿ II SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "THE MEDICATION RUNS OUT OF THE BACK OF THE CONE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372081 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211205

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown