BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12298183 · Received August 9, 2021

    Report

    Report Number
    3002682307-2021-00396
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    July 11, 2021
    Report Date
    October 27, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 2006428. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025. H.4. DEVICE MANUFACTURE DATE: 6/17/2020. D.4. MEDICAL DEVICE LOT #: 2012415. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2025. H.4. DEVICE MANUFACTURE DATE: 12/14/2020. D.4. MEDICAL DEVICE LOT #: 2006404. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025/ H.4. DEVICE MANUFACTURE DATE: 6/2/2020. D.4. MEDICAL DEVICE LOT #: 2006427. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025. H.4. DEVICE MANUFACTURE DATE: 6/17/2020. D.4. MEDICAL DEVICE LOT #: 2006429. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2025. H.4. DEVICE MANUFACTURE DATE: 6/17/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2006428, 2012415, 2006404, 2006427, AND 2006429. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS INCIDENT, THIRTY-FOUR SAMPLES WITH OPEN BLISTER PACKAGES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SYRINGES WERE EXAMINED AND SIX NEEDLES WERE FOUND BENT OUTSIDE OF SPECIFICATIONS, THREE OF THE BENT NEEDLES WERE FOUND TO BE SLIGHTLY BLUNT, ONE SYRINGE PRESENTED A SCALE MARKING ISSUE WHERE THE SCALE WAS LEGIBLE BUT SLIGHTLY BLURRED, AND NONE OF THE SYRINGES SHOWED SIGNS OF AIR BUBBLES. REGARDING THE SCALE MARKING ISSUE, AN UNEXPECTED MALFUNCTION WITH THE ROLLER SYSTEM WHICH TRANSFERS INK TO THE SYRINGE MUST HAVE OCCURRED, CAUSING THE SCALE TO PRINT SLIGHTLY BLURRED. AS OUR QUALITY TEAM WAS UNABLE TO REPRODUCE THE REPORTED DEFECT OF AIR BUBBLES, A CAUSE COULD NOT BE DETERMINED FOR THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MARKINGS ON THE SYRINGE SET AN ANGLE GIVING THE IMPRESSION THAT THEY ARE NOT STRAIGHT.

    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 SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MARKINGS ON THE SYRINGE SET AN ANGLE GIVING THE IMPRESSION THAT THEY ARE NOT STRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1195781 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown