BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE

    MDR report key: 7342175 · Received March 15, 2018

    Report

    Report Number
    1920898-2018-00130
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 23, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K955235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1CC SYRINGE. CUSTOMER STATES THAT THE SYRINGE HAS THINGS ON THE NEEDLE. THE PHOTO WAS EXAMINED AND NO FOREIGN MATTER WAS VISIBLE IN THE PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6242842. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Additional Manufacturer Narrative · 1

    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 BEFORE USE A BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE WAS FOUND WITH FOREIGN MATTER ON THE NEEDLES. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183382 BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6242842

    Patients

    Seq Age Sex Outcome Treatment
    1 Other