BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12557480 · Received September 30, 2021

    Report

    Report Number
    3002682307-2021-00529
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Date of Event
    September 2, 2021
    Report Date
    November 5, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K091377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-09-09. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2103419. 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 AND TWO PHYSICAL SAMPLES WITHOUT PACKAGING, ONE SAMPLE IN A SEALED PACKAGE, AND ONE OPENED SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. ALL OF THE RETURNED SAMPLES WERE EXAMINED AND THE SAMPLE WITH THE NEEDLE STILL IN THE VIAL SHOWED A DARK PIECE OF MATERIAL FLOATING IN THE BARREL. AFTER A FLUSH TEST WAS PERFORMED, THE SYRINGE AND THE FILTERS FROM EACH OF THE TEN FLUSHES WERE CHECKED. THE FOREIGN MATTER WAS NOT EXPELLED FROM THE BARREL DURING THE FLUSH TESTS. A PORTION OF THIS MATERIAL WAS REMOVED FOR FOURIER-TRANSFORM INFRARED (FTIR) SPECTRAL ANALYSIS. THE FTIR RESULTS SHOW THAT THE FLOATING FOREIGN MATTER WAS MOST LIKELY COMPOSED OF POLYCARBONATE. IT HAS BEEN DETERMINED THAT THIS FOREIGN PARTICLE MOST LIKELY RESULTED FROM POWDER IN THE SYRINGE ASSEMBLY PROCESS. DUE TO FRICTION BETWEEN PLASTIC RACKS AND THE ASSEMBLY MACHINERY RAILS, PLASTIC POWDER CAN BE PRODUCED. AN ACCUMULATION OF THIS POWDER COULD END UP IN THE SYRINGE DUE TO STATIC ELECTRICITY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FLU SYRINGE FOREIGN MATTER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1THERE WAS FOREIGN MATTER ON DEVICE CANNULA/NEEDLE/SYRINGE OR ANY FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "FLU SYRINGE FOREIGN MATTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453384 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2103419

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown