BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6MM BD¿ INSULIN SYRINGE

    MDR report key: 6809150 · Received August 21, 2017

    Report

    Report Number
    1920898-2017-00120
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 27, 2017
    Report Date
    October 13, 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
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 5110853. INVESTIGATION SUMMARY: 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 # 5110853 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. CAPA (B)(4) ¿ FM INTERNAL (SILICONE) INITIATED 15AUG2016. CORRECTIVE ACTIONS IMPLEMENTED (B)(6) 2016. LOT# 5110853 WAS PRODUCED PRIOR TO CORRECTIVE ACTIONS BEING IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LIQUID COMING FROM THE 6MM BD¿ INSULIN SYRINGE DURING INJECTION. MEDICAL INTERVENTIONS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589044 6MM BD¿ INSULIN SYRINGE INSLIN SYRINGE FMF BD MEDICAL - DIABETES CARE 5110853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other