BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 11155912 · Received January 12, 2021

    Report

    Report Number
    9616656-2020-01355
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    December 16, 2020
    Report Date
    February 23, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    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

    H6: INVESTIGATION SUMMARY O SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 PN 32G 4MM 5B XTW EASYFLOW LA EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMPLOYEE SIGNALED THAT TWO MORE NEEDLES FROM THE PREVIOUSLY CLAIMED LOT (0091882) AGAIN SHOWED A QUALITY DEVIATION: ONE WAS COMPLETELY CLOGGED AND THE OTHER WAS JUST DRIPPING GRADUALLY INSULIN AND NO COMPLETE EJECTION. CUSTOMER REMAINED WITH THE NEEDLE IN THE PEN AND MADE THREE ATTEMPTS, BUT THE NEEDLE REMAINED DIFFICULT TO EJECT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER LAST NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 PN 32G 4MM 5B XTW EASYFLOW LA EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EMPLOYEE SIGNALED THAT TWO MORE NEEDLES FROM THE PREVIOUSLY CLAIMED LOT (0091882) AGAIN SHOWED A QUALITY DEVIATION: ONE WAS COMPLETELY CLOGGED AND THE OTHER WAS JUST DRIPPING GRADUALLY INSULIN AND NO COMPLETE EJECTION. CUSTOMER REMAINED WITH THE NEEDLE IN THE PEN AND MADE THREE ATTEMPTS, BUT THE NEEDLE REMAINED DIFFICULT TO EJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51512 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 0091882

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR