BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7905603 · Received September 25, 2018

    Report

    Report Number
    1920898-2018-00735
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8143661. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN 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 AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE 1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE NEEDLE, THAT AN ORANGE SPECK WAS FOUND INSIDE THE BARREL OF THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 OF THE 1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE, THAT AN ORANGE SPECK WAS FOUND INSIDE THE BARREL OF THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746129 1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 8143661 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other