BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE

    MDR report key: 9272201 · Received November 4, 2019

    Report

    Report Number
    9616656-2019-01064
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 14, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NINETY TWO SEALED 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 9092789, CAT. NO. 320141. A CLOG TEST WAS CARRIED ON ALL NINETY TWO SAMPLES AS PER TP700483 AND NO ISSUES WERE OBSERVED. 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. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN WOULD NOT FLOW THROUGH THE BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "A PATIENT BROUGHT THIS BOX BACK TO THE PHARMACY WITH THE MESSAGE THAT THE NEEDLES DID NOT WORK. THIS PATIENT HAS BEEN USING THEM FOR YEARS AND A NURSE IS ALWAYS INJECTING THE INSULIN. NOW NOTHING CAME THROUGH THE NEEDLES. THERE WAS ALSO NO DROP AFTERWARDS."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN WOULD NOT FLOW THROUGH THE BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "A PATIENT BROUGHT THIS BOX BACK TO THE PHARMACY WITH THE MESSAGE THAT THE NEEDLES DID NOT WORK. THIS PATIENT HAS BEEN USING THEM FOR YEARS AND A NURSE IS ALWAYS INJECTING THE INSULIN. NOW NOTHING CAME THROUGH THE NEEDLES. THERE WAS ALSO NO DROP AFTERWARDS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065240 BD MICRO-FINE¿ ULTRA¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9092789

    Patients

    Seq Age Sex Outcome Treatment
    1 Other