BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 11417866 · Received March 4, 2021

    Report

    Report Number
    3002682307-2021-00080
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    February 8, 2021
    Report Date
    April 27, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE LOT# WAS PROVIDED, AND THE FOLLOWING FIELDS HAVE BEEN UPDATED: D2: MEDICAL DEVICE LOT#: 2011182. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. H4: DEVICE MANUFACTURE DATE: 2020-11-04.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2011182. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. IT HAS BEEN DETERMINED THAT THIS INCIDENT WAS MOST LIKELY A CONSEQUENCE OF DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE CAN RESULT DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VACCINE MEDICATION LEAKED PAST THE BD DISCARDIT¿ II SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: PROBLEMS OCCURRED AT THE VACCINATION CENTRE WHEN A VACCINE WAS DRAWN UP WITH THE SYRINGES "BD DISCARDIT II" IN CONNECTION WITH CANNULAS OF THE COMPANY WEIGAO MEDICAL INTERNATIONAL CO, LTD. ACCORDING TO THE USER, THE VACCINE GOT BEHIND THE CAVITY OF THE PLUNGER AND WAS THEREFORE NO LONGER AVAILABLE FOR VACCINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VACCINE MEDICATION LEAKED PAST THE BD DISCARDIT¿ II SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: PROBLEMS OCCURRED AT THE VACCINATION CENTRE WHEN A VACCINE WAS DRAWN UP WITH THE SYRINGES "BD DISCARDIT II" IN CONNECTION WITH CANNULAS OF THE COMPANY WEIGAO MEDICAL INTERNATIONAL CO, LTD. ACCORDING TO THE USER, THE VACCINE GOT BEHIND THE CAVITY OF THE PLUNGER AND WAS THEREFORE NO LONGER AVAILABLE FOR VACCINATION.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # [201124] WAS NOT FOUND FOR THE REPORTED CATALOG # [300928]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VACCINE MEDICATION LEAKED PAST THE BD DISCARDIT¿ II SYRINGE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: PROBLEMS OCCURRED AT THE VACCINATION CENTRE WHEN A VACCINE WAS DRAWN UP WITH THE SYRINGES "BD DISCARDIT II" IN CONNECTION WITH CANNULAS OF THE COMPANY WEIGAO MEDICAL INTERNATIONAL CO, LTD. ACCORDING TO THE USER, THE VACCINE GOT BEHIND THE CAVITY OF THE PLUNGER AND WAS THEREFORE NO LONGER AVAILABLE FOR VACCINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315045 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2011182

    Patients

    Seq Age Sex Outcome Treatment
    1