BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 14 PACK

    MDR report key: 10983128 · Received December 10, 2020

    Report

    Report Number
    3006948883-2020-00935
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 7, 2020
    Report Date
    December 21, 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#8152075 DHR AND RELATED MANUFACTURING RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. CLOG TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG FAIL FOUND. NO ACTUAL DEFECT SAMPLE RETURNED, SO A COMPREHENSIVE EVALUATION AND INVESTIGATION CANNOT BE CONDUCTED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NEEDLE 32GX4MM 14 PACK WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INJECTION NEEDLE WAS FOUND TO BE BLOCKED DURING THE USE OF THE DISPENSING SOLUTION, THE DISPENSING SOLUTION WAS CARRIED OUT NORMALLY AFTER BEING REPLACED IMMEDIATELY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NEEDLE 32GX4MM 14 PACK WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INJECTION NEEDLE WAS FOUND TO BE BLOCKED DURING THE USE OF THE DISPENSING SOLUTION, THE DISPENSING SOLUTION WAS CARRIED OUT NORMALLY AFTER BEING REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447329 PEN NEEDLE 32GX4MM 14 PACK PEN NEEDLE FMI BD (SUZHOU) 8152075

    Patients

    Seq Age Sex Outcome Treatment
    1