BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 11758472 · Received April 30, 2021

    Report

    Report Number
    9616656-2021-00456
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/30/2021. H.6. INVESTIGATION: CUSTOMER RETURNED 6 PEN NEEDLES WITH NO CAPS OR POUCH FOR IDENTIFICATION. EACH PEN NEEDLE WAS ATTACHED TO A SALINE TEST PEN. THE PEN WAS PRIMED AND SALINE WAS PUSHED THROUGH THE SYSTEM WITHOUT ISSUE. MINOR SIGNS OF USE WERE PRESENT BUT NO DAMAGE WAS FOUND. WHEN TESTED, ALL PEN NEEDLES FUNCTIONED AS INTENDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT #: 0133272; CATALOG #: 320109; DATE OF EVENT: UNKNOWN. NO "INJURIES OR HARM," BUT PROBLEM. I USE FOR INSULIN. I'VE USED ABOUT 30 NEEDLES FROM THIS BOX OF 100 & 3 OF THEM WERE BLOCKED. NO INSULIN CAME OUT WITH PRIMING DOSE, PEN RESISTS TURNING, FEELS LIKE THERE IS PRESSURE BUILT UP IN PEN. I CHANGED NEEDLES, INSTANT FIX, INSULIN COMES OUT, PROBLEM IS NOT PEN. I'VE ONLY SEEN THIS HAPPEN WITH 2 NEEDLES IN MY YEARS OF USE. I TOSSED THE 1ST NEEDLE THAT FAILED FROM THIS BOX.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0133272. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31 . DEVICE MANUFACTURE DATE: 2020-05-12. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD ULTRA FINE¿ PEN NEEDLES WERE UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT #: 0133272. CATALOG #: 320109. DATE OF EVENT: UNKNOWN. NO "INJURIES OR HARM," BUT PROBLEM. I USE FOR INSULIN. I'VE USED ABOUT 30 NEEDLES FROM THIS BOX OF 100 & 3 OF THEM WERE BLOCKED. NO INSULIN CAME OUT WITH PRIMING DOSE, PEN RESISTS TURNING, FEELS LIKE THERE IS PRESSURE BUILT UP IN PEN. I CHANGED NEEDLES, INSTANT FIX, INSULIN COMES OUT, PROBLEM IS NOT PEN. I'VE ONLY SEEN THIS HAPPEN WITH 2 NEEDLES IN MY YEARS OF USE. I TOSSED THE 1ST NEEDLE THAT FAILED FROM THIS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648386 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 SEE H10 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1