BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM

    MDR report key: 6947119 · Received October 13, 2017

    Report

    Report Number
    1920898-2017-00244
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 19, 2017
    Report Date
    December 3, 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
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 7093921. CUSTOMER STATES THAT THE NEEDLE STAYED IN THE VIAL. THE SYRINGE WAS RETURNED WITH APPROXIMATELY 60 UNITS OF A CLOUDY LIQUID INSIDE THE BARREL. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DETACHED CANNULA. THE LOOSE CANNULA WAS ALSO RETURNED WITH THE SAMPLE. THE SAMPLE WAS EXAMINED UNDER THE MICROSCOPE AND EXHIBITED ADHESIVE RUNOFF ONTO THE HUB. LITTLE ADHESIVE WAS OBSERVED INSIDE THE HUB. THE LOOSE CANNULA WAS ALSO EXAMINED AND EXHIBITED ADHESIVE ON THE CANNULA SHAFT. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7093921. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS 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: PROBABLE ROOT CAUSE DETERMINED TO BE MISALIGNMENT DURING APPLICATION OF ADHESIVE ON THE NEEDLE LINES. WHEN THIS OCCURS, ADHESIVE RUN-OVER ONTO THE HUB OR POSSIBLE THE CANNULA MAY OCCUR. ADDITIONALLY, ADHESIVE MAY BE INACCURATELY APPLIED TO THE RUBBERIZED PULL WHEEL ON THE LINE, WHICH CAN ADDITIONALLY TRANSFER ADHESIVE TO THE CANNULA DURING ROUTINE USE. (B)(4) INVESTIGATION SUMMARY: ON 21NOV2017, (B)(4) RECEIVED ONE (1) 1ML, 8MM, 31G SYRINGE AND LOOSE CANNULA IN OPENED POLYBAG FROM BATCH# 7093921. ALL SAMPLES WERE DECONTAMINATED PER (B)(4) PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, IT WAS NOTED THAT THE SAMPLE WAS RECEIVED WITH CLEAR LIQUID CONTAINING AN UNKNOWN FLUID AND PRECIPITATE WITHIN THE SYRINGE. THE BARREL TIP WAS VISUALIZED UNDER ULTRAVIOLET LIGHT, IT WAS NOTED THAT THE ADHESIVE APPEARED TO BE ALONG THE SIDE OF THE BARREL TIP, RATHER THAN DOWN THE CORE OF THE TIP. THE LOOSE CANNULA WAS ALSO VISUALIZED UNDER ULTRAVIOLET LIGHT AND NOTED SCANT TRACES OF ADHESIVE ALONG ITS EXTERIOR SURFACE. PROBABLE ROOT CAUSE IS LIKELY TO BE A MISALIGNMENT OF THE ADHESIVE NOZZLE DURING ASSEMBLY ON THE PILS (POINT INSPECT LUBE SHIELD) MACHINE. WHEN THIS OCCURS, THE ADHESIVE IS APPLIED TO THE INCORRECT PORTION OF THE BARREL TIP AND WHEN THE CANNULA IS INSERTED INTO THE BARREL TIP AND EXERCISED IN AND OUT, THE ADHESIVE IS NOT DISTRIBUTED AS INTENDED. THE CURING PROCESS WHICH FOLLOWS WOULD HARDEN THE ADHESIVE IN ITS PLACE AND POSSIBLY ONLY TEMPORARILY HOLD THE CANNULA IN PLACE. CAPA (B)(4) WAS INITIATED BY THE (B)(4) PLANT TO ADDRESS ADHESIVE RUN-OVER AND ITS ASSOCIATE ROOT CAUSE(S). BATCH# 7093921 WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF CORRECTIVE/PREVENTATIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM THE NEEDLE REMAINED IN THE VIAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729372 BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7093921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other