BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY

    MDR report key: 7180516 · Received January 10, 2018

    Report

    Report Number
    1920898-2017-00430
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Date of Event
    December 11, 2017
    Report Date
    March 12, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055365
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A TRAY OF 1/2ML, 10MM, 27G ALLERGY SYRINGES FROM LOT # 7072704. CUSTOMER STATES THAT THE LABEL HAD "TREATMENT" CROSSED OUT AND "TESTING" WAS WRITTEN. THE PHOTO WAS EXAMINED AND THE TRAY COVER EXHIBITED ¿TREATMENT¿ PRINTED ON IT. REFER TO CAPA (B)(4) AND SITUATION ANALYSIS (B)(4). BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: REFER TO CAPA (B)(4) AND SITUATION ANALYSIS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL OF A BD ALLERGY TRAY PRECISIONGLIDE¿ ATTACHED NEEDLE WITHOUT SAFETY WAS INCORRECT, AND STATED ¿TREATMENT¿ INSTEAD OF ¿TESTING¿ ON THE LABEL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24179 BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7072704 30382903055365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other