BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6824809 · Received August 28, 2017

    Report

    Report Number
    1920898-2017-00130
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 4, 2017
    Report Date
    November 17, 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
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1CC SYRINGE. CUSTOMER STATES THAT THE NEEDLE BROKE OFF INTO THE VIAL WHILE DRAWING. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A DETACHED CANNULA. THE LOOSE CANNULA WAS RETURNED IN THE SHIELD OF THE SYRINGE. THE SAMPLE WAS ALSO EXAMINED UNDER THE MICROSCOPE AND UNDER UV LIGHT AND EXHIBITED ADHESIVE RUNOFF ONTO THE HUB AND LITTLE ADHESIVE IN THE HUB OF THE SYRINGE. THE LOOSE CANNULA ALSO EXHIBITED ADHESIVE ON THE CANNULA SHAFT. SAMPLE WILL BE FORWARDED TO MANUFACTURING ((B)(4)) ON 06OCT2017 FOR FURTHER INVESTIGATION. AS PER MANUFACTURING, THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY RELATED DEFECTS DURING THE PRODUCTION OF THESE BATCHES. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: 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. THE PROBABLE ROOT CAUSES FOR THIS ISSUE ARE: MISADJUSTMENT OF THE ADHESIVE NOZZLE; FLOW ON ADHESIVE NOZZLE IS SET TOO HIGH. BASED ON THE ABOVE, NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: (B)(4) RECEIVED ONE (1) 1ML, 8MM, 30G SYRINGE IN OPENED POLYBAG FROM BATCH# 7023647. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE FOUND IN (B)(6) WERE NOTED WITH NO ADDITIONAL INFORMATION TO BE PROVIDED AT THIS TIME. THE (B)(4) PLANT RECENTLY UPGRADED THE NEEDLE LINES WITH ADDITIONAL LIGHTING AND CAMERA UPGRADES WITH THE INTENT OF BETTER DETECTION OF ADHESIVE RUNOFF AND/OR INSUFFICIENT ADHESIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WILE DRAWING UP MEDICATION WITH THE BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM, THE NEEDLE SEPARATED FROM THE HUB. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605369 BD RELION® INSULIN SYRINGE 1 ML, 31 G X 8 MM INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7023647

    Patients

    Seq Age Sex Outcome Treatment
    1 Other