BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 13966962 · Received March 31, 2022

    Report

    Report Number
    9616657-2022-00008
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 11, 2022
    Report Date
    April 13, 2022
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 #: 1021328, MEDICAL DEVICE EXPIRATION DATE: 2026-01-31, DEVICE MANUFACTURE DATE: 2021-03-31; MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12-APR-2022 . H.6. INVESTIGATION: CUSTOMER RETURNED A TOTAL OF 8 USED 4MM, 32 GAUGE NANO PEN NEEDLES. THE TEAR DROP LABELS WERE NOT RETURNED FOR FURTHER IDENTIFICATION. THE PEN NEEDLES WERE VISUALLY INSPECTED PRIOR TO TESTING. ALL 8 OF THE PEN NEEDLES WERE FOUND TO HAVE BENT NEEDLES ON THE NON-PATIENT SIDE OF THE HUB¿S NEEDLE CANNULA. THIS DAMAGE WOULD PREVENT TESTING FOR CLOGS SINCE THE NEEDLE CANNOT PROPERLY ATTACH TO THE PEN. AS A RESULT, THE PEN NEEDLES APPEAR TO BE CLOGGED DURING USE. BASED ON THE DAMAGE PRESENT, THE NEEDLES BENDING MAY HAVE OCCURRED ACCIDENTALLY WHILE THE USER WAS PREPARING THE PEN NEEDLE FOR USE, POTENTIALLY IF THE PEN WAS NOT PROPERLY ALIGNED WITH THE CANNULA. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. BASED ON THE SAMPLES RECEIVED, BD FOUND THAT THE PEN NEEDLES HAD BECOME BENT ON THE NON-PATIENT SIDE. THIS DAMAGE COULD RESEMBLE THE NEEDLE BEING CLOGGED AS A RESULT OF INSULIN NOT PASSING THROUGH THE NEEDLE. THE ROOT CAUSE OF THE NEEDLES BENDING APPEARS TO BE ACCIDENTAL DAMAGE FROM STRESSES CAUSED BY THE USER DURING ROUTINE USE. THIS WOULD HAVE ALSO GIVEN THE IMPRESSION THAT THE NEEDLE WAS CLOGGED SINCE INSULIN WOULD BE UNABLE TO PASS THROUGH THE CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NANO¿ ULTRA-FINE¿ PEN NEEDLES WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE LAST 6-8 MONTHS I HAVE EXPERIENCED AN INCREASE IN PEN NEEDLES THAT HAVEN'T BEEN WORKING. I'VE HAD TO USE 2 AND EVEN SOMETIMES 3 NEEDLES TO FIND ONE THAT WORKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NANO¿ ULTRA-FINE¿ PEN NEEDLES WERE UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE LAST 6-8 MONTHS I HAVE EXPERIENCED AN INCREASE IN PEN NEEDLES THAT HAVEN'T BEEN WORKING. I'VE HAD TO USE 2 AND EVEN SOMETIMES 3 NEEDLES TO FIND ONE THAT WORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042297 BD NANO¿ ULTRA-FINE¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON AND CO. 2865 UNKNOWN 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown