BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PEN NEEDLE

    MDR report key: 10954165 · Received December 5, 2020

    Report

    Report Number
    2243072-2020-02004
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 17, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT #: 0041572 H.6. INVESTIGATION: MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. APPEARANCE, NP GAP AND CLOG TEST WERE INSPECTED FOR 7PCS RETENTION PARTS, ALL RESULTS PASSED. NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES FOR INVESTIGATION, SO WE CAN¿T PERFORM IN-DEPTH INVESTIGATION. THE CERTAIN CAUSE CAN¿T BE CONCLUDED AT THE MOMENT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD PEN NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, A CUSTOMER COME TO PHARMACY SOUTH ROAD STORE TO BUY MEDICINE, THE SHOP ASSISTANT ASKED HIS DIABETES FOR MANY YEARS, HAS BEEN PLAYING INSULIN, HOME OF DISPOSABLE INJECTION WITH A NEEDLE, THE EMPLOYEE ASK THE CUSTOMER TO BUY MODEL, AND THEN TO THE CUSTOMER TOOK THE BOX OF DISPOSABLE INJECTION WITH A NEEDLE TO CUSTOMERS. THE CUSTOMER USED INSULIN AT HOME. THE EMPLOYEE LOOKED AT IT AND FOUND THAT THE NEEDLE WAS BENT. THE REPLY WAS THAT THE NEEDLE MIGHT BE BENT AND BLOCKED.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE LOT #: AN INVALID LOT # OF 0041572 WAS PROVIDED BY THE INITIAL REPORTER 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 AN UNSPECIFIED BD PEN NEEDLE WAS UNABLE TO DELIVER INSULIN/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, A CUSTOMER COME TO (B)(6) STORE TO BUY MEDICINE, THE SHOP ASSISTANT ASKED HIS DIABETES FOR MANY YEARS, HAS BEEN PLAYING INSULIN, HOME OF DISPOSABLE INJECTION WITH A NEEDLE, THE EMPLOYEE ASK THE CUSTOMER TO BUY MODEL, AND THEN TO THE CUSTOMER TOOK THE BOX OF DISPOSABLE INJECTION WITH A NEEDLE TO CUSTOMERS. THE CUSTOMER USED INSULIN AT HOME. THE EMPLOYEE LOOKED AT IT AND FOUND THAT THE NEEDLE WAS BENT. THE REPLY WAS THAT THE NEEDLE MIGHT BE BENT AND BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419258 UNSPECIFIED BD PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON 0041572

    Patients

    Seq Age Sex Outcome Treatment
    1