BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES

    MDR report key: 8487388 · Received April 5, 2019

    Report

    Report Number
    9616656-2019-00313
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 11, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ NANO¿ PEN NEEDLES HAD NO INSULIN FLOW DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ PARENT OF CONSUMER REPORTED DURING INJECTION, NO INSULIN FLOW. HE PROVIDED TWO LOT NUMBERS AND DESCRIPTION OF PEN NEEDLES USED. USING A NANO PEN NEEDLE AND MINI PEN NEEDLE. DISCARDED SAMPLES. LOT: 7101669 FOR NANO, LOT: 5161322 FOR MINI PEN NEEDLES. STATED HE WAS READING INFORMATION FROM ACTUAL PEN NEEDLE. BOXES DISCARDED. STATED HE AND HIS SON ARE DIABETICS AND THEY ARE SHARING PEN NEEDLES. CONSUMER NOT SURE WHICH PEN NEEDLE HAD THE ISSUE, MINI OR NANO. USES A FLEX PEN.¿

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES HAD NO INSULIN FLOW DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿PARENT OF CONSUMER REPORTED DURING INJECTION, NO INSULIN FLOW. HE PROVIDED TWO LOT NUMBERS AND DESCRIPTION OF PEN NEEDLES USED. USING A NANO PEN NEEDLE AND MINI PEN NEEDLE. DISCARDED SAMPLES. LOT: 7101669 FOR NANO, LOT: 5161322 FOR MINI PEN NEEDLES. STATED HE WAS READING INFORMATION FROM ACTUAL PEN NEEDLE. BOXES DISCARDED. STATED HE AND HIS SON ARE DIABETICS AND THEY ARE SHARING PEN NEEDLES. CONSUMER NOT SURE WHICH PEN NEEDLE HAD THE ISSUE, MINI OR NANO. USES A FLEX PEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282749 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES PEN NEEDLE FMI BECTON DICKINSON AND CO. 7101669 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other