BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12200541 · Received July 20, 2021

    Report

    Report Number
    3002682307-2021-00336
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 6, 2021
    Report Date
    August 9, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K091377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2012414. 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 ISSUE, A PICTURE SAMPLE WAS RETURNED FOR ANALYSIS BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A SMALL BROWN FOREIGN PARTICLE COULD BE OBSERVED WITHIN THE FLUID PATHWAY. WITHOUT THE AFFECTED PHYSICAL SAMPLE, WE ARE NOT ABLE TO CHARACTERIZE THE NATURE OF THE BROWN PARTICLE. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VACCINATOR WAS DRAWING UP THE FIRST DOSE OF ASTRAZENECA, AS HE FILLED THE SYRINGE WITH THE VACCINE HE NOTICED PARTICULATE MATTER FLOATING IN THE SYRINGE. HE CHECKED THE VIAL BEFORE DRAWING UP THE DOSE AND DIDN'T NOTICE ANYTHING UNTOWARD, HE THINKS THE PARTICULATE WAS FROM THE SYRINGE, BUT CANNOT BE COMPLETELY SURE WHERE THE PARTICULATE ORIGINALLY CAME FROM. THE DRAWN UP PART DOSE WAS LEFT IN THE SYRINGE AND THE REMAINING DOSES IN THE VIAL WERE RETURNED TO PHARMACY, NOTHING WAS GIVEN TO A PATIENT. I HAVE TAKEN AND ATTACHED A PICTURE OF THE SYRINGE WITH THE PARTICULATE MATTER IN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VACCINATOR WAS DRAWING UP THE FIRST DOSE OF ASTRAZENECA, AS HE FILLED THE SYRINGE WITH THE VACCINE HE NOTICED PARTICULATE MATTER FLOATING IN THE SYRINGE. HE CHECKED THE VIAL BEFORE DRAWING UP THE DOSE AND DIDN'T NOTICE ANYTHING UNTOWARD, HE THINKS THE PARTICULATE WAS FROM THE SYRINGE, BUT CANNOT BE COMPLETELY SURE WHERE THE PARTICULATE ORIGINALLY CAME FROM. THE DRAWN UP PART DOSE WAS LEFT IN THE SYRINGE AND THE REMAINING DOSES IN THE VIAL WERE RETURNED TO PHARMACY, NOTHING WAS GIVEN TO A PATIENT. I HAVE TAKEN AND ATTACHED A PICTURE OF THE SYRINGE WITH THE PARTICULATE MATTER IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093909 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012414

    Patients

    Seq Age Sex Outcome Treatment
    1