BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 9587284 · Received January 14, 2020

    Report

    Report Number
    9616656-2019-01320
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 16, 2020
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE CLOG & DOES NOT ATTACH/DETACH ON LOT # 9162522. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO AN UNKNOWN LOT NUMBER. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122. BATCH NO: 9162522, UNKNOWN . IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED NEEDLE CLOG AND DIFFICULTY TO ATTACH PEN NEEDLE ON THE PEN. CUSTOMER REPORTED THE SAME ISSUE IN THE PAST UNKNOWN LOT#. VERBATIM: CONSUMER REPORTED IN THE LAST YEAR, HE'S FOUND PROBLEMS WITH AT LEAST 10% OF HIS PEN NEEDLES. MORE THAN ONE BOX WAS AFFECTED BUT HE'S ONLY REPORTING ONE BOX TODAY. STATED, SOME WILL NOT RELEASE INSULIN WHEN TAKING INJECTIONS STATED, SOME HE HAS A HARD TIME ATTACHING PEN NEEDLES TO INSULIN PEN NO INJURY TO REPORT DOES NOT PRIME BEFORE USE DISCARDED SAMPLES LOT: 9162522. OTHER LOT'S UNKNOWN AND HOW MANY BOXES INVOLVED OVER THE YEAR, UNKNOWN. ITEM: 320122. EXPIRATION DATE: 2024-06-30 INCIDENT DATES UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9162522. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2019-06-11. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HAS BEEN FOUND EXPERIENCING INABILITY TO PRIME DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122 BATCH NO: 9162522, UNKNOWN. IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED NEEDLE CLOG AND DIFFICULTY TO ATTACH PEN NEEDLE ON THE PEN. CUSTOMER REPORTED THE SAME ISSUE IN THE PAST UNKNOWN LOT#. VERBATIM: CONSUMER REPORTED IN THE LAST YEAR, HE'S FOUND PROBLEMS WITH AT LEAST 10% OF HIS PEN NEEDLES. MORE THAN ONE BOX WAS AFFECTED BUT HE'S ONLY REPORTING ONE BOX TODAY. STATED, SOME WILL NOT RELEASE INSULIN WHEN TAKING INJECTIONS. STATED, SOME HE HAS A HARD TIME ATTACHING PEN NEEDLES TO INSULIN PEN. NO INJURY TO REPORT. DOES NOT PRIME BEFORE USE. DISCARDED SAMPLES. LOT: 9162522. OTHER LOT'S UNKNOWN AND HOW MANY BOXES INVOLVED OVER THE YEAR, UNKNOWN. ITEM: 320122. EXPIRATION DATE: 2024-06-30. INCIDENT DATES UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52116 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other