BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 9084492 · Received September 18, 2019

    Report

    Report Number
    3006948883-2019-00778
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY 1. LOT#8123364 DHR WAS REVIEWED AND NO QN FOUND. 2. LOT#8123364 MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMAL WAS FOUND. 3. VISUAL INSPECTION OF NEEDLE THROUGH SHIELD AND NEEDLE BENT TESTING WAS CONDUCTED ON 14PCS RETENTION SAMPLES, THE RESULT MEET SPECIFICATION REQUIREMENT. 4. PEN NEEDLE PRODUCT HAS 100% NEEDLE THROUGH SHIELD INSPECTION BY VISION INSPECTION SYSTEM, AND DEFECT PART WILL REJECTED BY POINT VISION SYSTEM STATION AUTOMATICALLY. 5. NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES FOR INVESTIGATION, SO WE CAN¿T PERFORMING IN-DEPTH INVESTIGATION. 6. BASE ON THE INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE CANNULA WAS POKING OUT OF THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: IT'S NOTICED THAT CANNULA THROUGH SHIELD.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE CANNULA WAS POKING OUT OF THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT'S NOTICED THAT CANNULA THROUGH SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879095 BD ULTRA FINE¿ PEN NEEDLE PEN NEEDLE FMI BD (SUZHOU) 8123364

    Patients

    Seq Age Sex Outcome Treatment
    1 Other