BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION® INSULIN SYRINGE

    MDR report key: 7311196 · Received March 2, 2018

    Report

    Report Number
    1920898-2018-00142
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    January 1, 2018
    Report Date
    March 5, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311748
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 6TH RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7023647. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 7023647. CUSTOMER STATES THAT WHEN REMOVING THE SYRINGE THE NEEDLE BREAKS OFF OF THE HUB AND COMES OFF INSIDE OF THE SYRINGE. BOTH RETURNED SYRINGES WERE EXAMINED AND NO DEFECTS WERE OBSERVED ON EITHER OF THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7023647. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE SEVEN (7) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE HUB OF A RELION® INSULIN SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154799 RELION® INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023647 00681131311748

    Patients

    Seq Age Sex Outcome Treatment
    1 Other