BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 5MM XTW 5B 100CT AP

    MDR report key: 10248504 · Received July 8, 2020

    Report

    Report Number
    3006948883-2020-00282
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 9, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 1. LOT#9032842 DHR WAS REVIEWED AND NO QN FOUND. 2. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. 3. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL BE REJECTED BY FLOWGURU STATION AUTOMATICALLY. 4. CLOG AND NP GAP TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG OR NP GAP FAIL FOUND. 5. NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES FOR INVESTIGATION, SO WE CAN¿T PERFORMING IN-DEPTH INVESTIGATION. BASE ON INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 31G 5MM XTW 5B 100CT AP WAS BLOCKED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES WERE BLOCKED.

    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 NDL 31 G 5 MM XTW 5B 100 CT AP WAS BLOCKED ON 10 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLES WERE BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712762 PEN NDL 31G 5MM XTW 5B 100CT AP PEN NEEDLE FMI BD (SUZHOU) 9032842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other