BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RELION® INSULIN SYRINGE

    MDR report key: 7280525 · Received February 19, 2018

    Report

    Report Number
    1920898-2018-00050
    Event Type
    Malfunction
    Date Received
    February 19, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 20, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 7072997. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 3/10CC, 6MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 7072997. CUSTOMER STATES THAT THE SYRINGES SEEM TO HAVE A BLOOD LIKE SUBSTANCE TOWARDS THE TIP OF THE BARREL. THE RETURNED SYRINGE WAS EXAMINED VISUALLY AND UNDER THE MICROSCOPE AND EXHIBITED A REDDISH MATERIAL ON THE OUTER SURFACE OF THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SUGGESTS THAT THIS MATERIAL HAS COMPONENTS SIMILAR TO THOSE OF BLOOD. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7072997. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE FIVE (5) NOTIFICATIONS [200690274, 200690273, 200690277, 200690692, 200690278] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BLOOD ON SURFACE OF BARREL) BUT THIS MATERIAL WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. IT IS POSSIBLE IT CAME FROM THE CUSTOMER. 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

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 BY A CONSUMER THAT SOME OF THE RELION® INSULIN SYRINGES WERE FOUND TO HAVE ¿BLOOD LIKE SUBSTANCE¿ TOWARDS THE TIP OF THE BARREL. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124515 BD RELION® INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7072997 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other