BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM 5B XTW EASYFLOW LA

    MDR report key: 10915963 · Received November 28, 2020

    Report

    Report Number
    9616656-2020-01195
    Event Type
    Malfunction
    Date Received
    November 28, 2020
    Date of Event
    November 6, 2020
    Report Date
    November 17, 2020
    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 · 1

    DATE OF EVENT: UNKNOWN. 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 11 PN 32G 4MM 5B XTW EASYFLOW LA EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT CONTACTED US TO REPORT A POSSIBLE QUALITY DEVIATION IN THE BD ULTRA-FINE 4MM EASY FLOW NEEDLES (LOT: 0091882; MANUFACTURE: 04/2020; VALIDITY: 03/2025). HE REPORTS THAT HE RECENTLY STARTED TO USE INSULIN, AROUND 15 DAYS AGO AND IS USING BD ULTRA-FINE NEEDLES, BUT IN THIS BATCH, 10 NEEDLES CAUSED THE FOLLOWING QUALITY DEVIATION: INSULIN EJECTION IS NOT OCCURRING, ¿IT SEEMS TO BE HARDER FOR PRESS THE INSULIN PEN AND MAKE THE APPLICATION, NOTHING COMES OUT," MENTIONED THE CLIENT. THE PATIENT UNDERWENT THE FLOW TEST AND NO EJECTION OCCURRED. DO NOT REUSE NEEDLES. REQUESTED PRODUCT REPLACEMENT. REGARDING THE PEN GETTING HARD WHEN PRESSING DURING THE APPLICATION, HE REPORTS THAT HE NOTICED IT WHEN TRYING TO APPLY THE MEDICINE WITH ONE OF THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380362 PN 32G 4MM 5B XTW EASYFLOW LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 0091882

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR