BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ II

    MDR report key: 7059704 · Received November 27, 2017

    Report

    Report Number
    1920898-2017-00328
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 1, 2017
    Report Date
    December 18, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (60) 1CC, 8MM, 31G SYRINGES IN SEALED POLY BAGS WITH THE SHELF CARTON FROM LOT # 6172771. CUSTOMER STATES THAT THE BARREL IS TOO TIGHT FOR THE PLUNGER. THIRTY RETURNED SYRINGES WERE TESTED AND ALL PLUNGER RODS WERE ABLE TO EASILY MOVE THROUGH THE BARREL WITHOUT ANY OBSERVED DEFECTS. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6172771. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED FOR THE COMPLAINT. INVESTIGATION CONCLUSION: BD WAS NOT 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ON A BD ULTRA FINE¿ II IS HARD TO DEPRESS DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841529 BD ULTRA FINE¿ II INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6172771

    Patients

    Seq Age Sex Outcome Treatment
    1 Other