BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

    MDR report key: 12081491 · Received June 28, 2021

    Report

    Report Number
    3002682307-2021-00288
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    September 24, 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 BD MATERIAL 305832 AND LOT NUMBER 2012416. 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 BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A CANNULATED BARREL WAS OBSERVED WITHOUT A PLUNGER OR SHIELD COMPONENT, CONFIRMING A PRODUCT DEFECT. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED FROM A FAULTY SYRINGE GOING THROUGH THE PACKAGING MACHINE; HOWEVER, THE EXACT CAUSE FOR THE INTRODUCTION OF THIS FAULTY SYRINGE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 EXPERIENCED A BENT TIP OF THE SYRINGE AND THE PACKAGING WAS BREACHED BY THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEE BELOW NEEDLE WE HAVE FOUND.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). 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 THAT THE SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 EXPERIENCED A BENT TIP OF THE SYRINGE AND THE PACKAGING WAS BREACHED BY THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEE BELOW NEEDLE WE HAVE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976638 SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1 PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012416

    Patients

    Seq Age Sex Outcome Treatment
    1