BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12206762 · Received July 21, 2021

    Report

    Report Number
    3002682307-2021-00343
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 9, 2021
    Report Date
    August 31, 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2012415. 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 EVALUATION; HOWEVER, WITH JUST THE PICTURE ALONE, OUR QUALITY ENGINEER TEAM WAS NOT ABLE TO CONFIRM THE REPORTED INCIDENT. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED DEFECT.

    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: PARTICULATE FLOATING IN THE BODY OF THE SYRINGE, NOT APPROPRIATE TO USE.

    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: PARTICULATE FLOATING IN THE BODY OF THE SYRINGE, NOT APPROPRIATE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104460 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012415

    Patients

    Seq Age Sex Outcome Treatment
    1