BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOSHOT¿ MINI

    MDR report key: 12665982 · Received October 20, 2021

    Report

    Report Number
    3002682307-2021-00562
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 5, 2021
    Report Date
    October 21, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102429. 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. TO AID IN THE INVESTIGATION OF THIS INCIDENT, PICTURE AND VIDEO SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, A BLACK FOREIGN PARTICLE WAS IDENTIFIED WITHIN THE FLUID PATHWAY OF THE SYRINGE. HOWEVER, WITHOUT THE PHYSICAL SAMPLE, IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE FOREIGN MATTER NOR A CORRESPONDING MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SOLOSHOT¿ MINI, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AN INCIDENT WAS RECENTLY REPORTED TO WHO RELATED TO A BD PRODUCT USED IN GAZA. A NURSE ADMINISTERING COVID-19 VACCINES HAD SEEN A ¿BLACK PARTICLE WAS FOUND IN THE VIAL OF MODERNA VACCINE USED IN GAZA¿. THE DATE OF THE INCIDENT AND PRECISE LOCATION HAVE NOT BEEN REPORTED TO WHO. SYRINGE - BUT NOT THE VIAL. THEREFORE, IT IS IMPORTANT TO ENSURE TO INVESTIGATE THIS CASE AS A MEDICAL DEVICE INCIDENT AS WELL.

    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 WHEN USING THE BD SOLOSHOT¿ MINI, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AN INCIDENT WAS RECENTLY REPORTED TO WHO RELATED TO A BD PRODUCT USED IN (B)(6). A NURSE ADMINISTERING COVID-19 VACCINES HAD SEEN A ¿BLACK PARTICLE WAS FOUND IN THE VIAL OF MODERNA VACCINE USED IN (B)(6)¿. THE DATE OF THE INCIDENT AND PRECISE LOCATION HAVE NOT BEEN REPORTED TO WHO. SYRINGE - BUT NOT THE VIAL. THEREFORE, IT IS IMPORTANT TO ENSURE TO INVESTIGATE THIS CASE AS A MEDICAL DEVICE INCIDENT AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566017 BD SOLOSHOT¿ MINI SYRINGE FMF BECTON DICKINSON, S.A. 2102429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown