BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31X5

    MDR report key: 8224104 · Received January 7, 2019

    Report

    Report Number
    3006948883-2018-00343
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 14, 2018
    Report Date
    February 4, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR OF LOT 8030495 WAS REVIEWED AND NO QN FOUND. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. SUZHOU PLANT HAS 100% VISUAL INSPECTION SYSTEM TO DETECT BENT AND MISSING NP CANNULAS, AND REJECT DEFECT PART AUTOMATICALLY. RETURNED SAMPLE WAS TESTED ON NP END VISUAL INSPECTION SYSTEM AND THE SAMPLE WAS REJECTED BY VISION INSPECTION SYSTEM. INCOMING INSPECTION REPORT OF THE CANNULA WHICH USED FOR THIS LOT, AND ALL TEST RESULTS MEET THE SPECIFICATION; BASE ON INVESTIGATION ABOVE, THE COMPLAINT IS NOT MANUFACTURE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NEEDLE 31X5 WAS UNABLE TO DELIVER INSULIN.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 A PEN NEEDLE 31X5 WAS UNABLE TO DELIVER INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15119 PEN NEEDLE 31X5 PEN NEEDLE FMF BD (SUZHOU) 8030495

    Patients

    Seq Age Sex Outcome Treatment
    1 Other