BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML POSIFLUSH LA

    MDR report key: 11680477 · Received April 16, 2021

    Report

    Report Number
    1911916-2021-00332
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS REPORTED THE SYRINGE CAME WITH A DUPLICATE LABEL. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH A DOUBLE BARREL LABEL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT CAN OCCUR IF THERE IS A JAM AT THE LABEL MACHINE INDUCING THE DOUBLE LABEL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306565, LOT NUMBER 0191891. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML POSIFLUSH LA HAD LABEL ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE CAME WITH A DUPLICATE LABEL, PREVENTING THE INFORMATION FROM BEING DISPLAYED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 10ML POSIFLUSH LA HAD LABEL ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE CAME WITH A DUPLICATE LABEL, PREVENTING THE INFORMATION FROM BEING DISPLAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577980 SYRINGE 10ML POSIFLUSH LA SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0191891

    Patients

    Seq Age Sex Outcome Treatment
    1