BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 25X1

    MDR report key: 12104208 · Received July 1, 2021

    Report

    Report Number
    3002682307-2021-00297
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 16, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/9/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1905414. 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, BOTH A PICTURE SAMPLE AND THE PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE PICTURE SAMPLE SHOWED THE FLU PLUS SYRINGE WITH A GREYISH-BLACK FOREIGN MATTER IN THE FLUID PATH. THE PHYSICAL SAMPLE WAS RETURNED WITH A CLEAR LIQUID IN THE BARREL AND A GRAYISH PIECE OF MATERIAL FLOATING IN THE LIQUID. THE PARTICLE WAS EXAMINED THROUGH FOURIER-TRANSFORM INFRARED SPECTRAL ANALYSIS, WHICH DETERMINED THAT THE COMPOSITION WAS MAINLY POLYCARBONATE. IT HAS BEEN CONCLUDED THAT THIS FOREIGN MATERIAL CONSISTS OF POWDER FROM RACKS IN THE ASSEMBLY PROCESS. IN ORDER TO MOVE THE PRODUCT PIECES THROUGH THE ASSEMBLY PROCESS, THE SYRINGES ARE PLACED WITHIN PLASTIC RACKS. DUE TO FRICTION BETWEEN THE RACKS AND THE MACHINE RAILS, SMALL PLASTIC POWDER CAN BE GENERATED. THE ACCUMULATION OF RACK POWDER COULD END UP IN THE SYRINGE DUE TO STATIC ELECTRICITY. BASED ON THE PREVENTIVE MEASURES IN PLACE AND OUR STRINGENT SAMPLING INSPECTION AND CLEANING PROGRAM, WE ARE CONFIDENT THAT THE PROBABILITY OF THIS ISSUE RECURRING IS VERY LOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE FLU PLUS 0.25-1ML VAR DOSE 25X1 HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "FM OBSERVED IN SYRINGE DURING COVID-19 VACCINATION".

    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 A SYRINGE FLU PLUS 0.25-1ML VAR DOSE 25X1 HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "FM OBSERVED IN SYRINGE DURING COVID-19 VACCINATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997248 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 25X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1905414

    Patients

    Seq Age Sex Outcome Treatment
    1