BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 14 PACK

    MDR report key: 10954138 · Received December 5, 2020

    Report

    Report Number
    3006948883-2020-00889
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    September 29, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: LOT#0042806 DHR AND RELATED MANUFACTURING RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL BE REJECTED BY FLOWGURU STATION AUTOMATICALLY. CLOG AND NP GAP TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG OR NP GAP FAIL FOUND. NO ACTUAL DEFECT SAMPLE RETURNED, SO A COMPREHENSIVE EVALUATION AND INVESTIGATION CANNOT BE CONDUCTED. THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NEEDLE 32GX4MM 14 PACK WAS BLOCKED AND WOULDN'T DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT INJECTED INSULIN AT HOME, DID NOT RESPOND TO PLUNGE DOWN, FOUND THAT THE INSULIN NEEDLE WAS BLOCKAGE, A NEW NEEDLE WAS REPLACED"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NEEDLE 32GX4MM 14 PACK WAS BLOCKED AND WOULDN'T DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT INJECTED INSULIN AT HOME, DID NOT RESPOND TO PLUNGE DOWN, FOUND THAT THE INSULIN NEEDLE WAS BLOCKAGE, A NEW NEEDLE WAS REPLACED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418442 PEN NEEDLE 32GX4MM 14 PACK HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 0042806

    Patients

    Seq Age Sex Outcome Treatment
    1