BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ULTRA-FINE

    MDR report key: 7342183 · Received March 15, 2018

    Report

    Report Number
    1920898-2018-00146
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    June 12, 2017
    Report Date
    March 20, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 6123811. INVESTIGATION SUMMARY: CUSTOMER RETURNED (34) 1CC, 12.7MM, 29G SYRINGES (4 LOOSE WITHOUT ANY PACKAGING, 30 IN SEALED BLISTER PACKS) FROM LOT # 6123811. CUSTOMER STATES THAT THE SYRINGES WERE LEAKING. ALL RETURNED SYRINGES WERE TESTED AND ALL SAMPLES WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY LEAKAGE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6123811. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). INITIAL REPORTER FAX#: (B)(6). 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 THE BD¿ ULTRA-FINE FAILED TO CONTAIN THE PRODUCT AND LEAKED FLUID. FOUND DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185339 BD¿ ULTRA-FINE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6123811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other