BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT

    MDR report key: 10019079 · Received May 1, 2020

    Report

    Report Number
    1920898-2020-00454
    Event Type
    Injury
    Date Received
    May 1, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 17, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9070627 . MEDICAL DEVICE EXPIRATION DATE: 2024-03-31 . DEVICE MANUFACTURE DATE: 2019-03-11. MEDICAL DEVICE LOT #: UNKNOWN . MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_3__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR SCALE MISALIGNED AND THE 1ST RELATED COMPLAINT FOR HYPERGLYCEMIA ON LOT # 9070627. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR SCALE MISALIGNED AND HYPERGLYCEMIA FOR UNKNOWN LOT NUMBER. INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF SYRINGE. CUSTOMER STATES THAT THERE ARE INCONSISTENCIES WHERE THE FIRST LINE STARTS AND THE NUMBERS HAVE BEEN HIGH. THE PHOTOS WERE EXAMINED AND IT IS DIFFICULT TO DETERMINE IF THE SCALE MARKINGS FALL OUT OF SPECIFICATIONS OR TO MEASURE THE VOLUMETRIC ACCURACY SOLELY FROM THE PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070627. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS (B)(4) NOTED FOR SCRATCH PRINT. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED FOR INK RINGS. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: - UNCONFIRMED: 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 6MM HALFUNIT EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTED DURING USE. THE DEVICES WERE ALSO INVOLVED IN A SERIOUS INJURY IN THE FORM OF HYPERGLYCEMIA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 324910; BATCH NO. 9070627. I CONTACTED BD BECAUSE I HAVE BEEN NOTICING A DISCREPANCY IN THE HASHMARKS ON THE SYRINGES THAT I USE FOR MY DAUGHTER'S INSULIN. WE USE AN INSULIN PEN FOR HER BOLUS DOSES ONCE A DAY, BASAL DOSE WE USE A SYRINGE BECAUSE WE OFTEN NEED TO CHANGE HER DOSE BY 1/2 OR EVEN 1/4 UNIT INCREMENTS AND THE LANTUS (BASAL) PENS ONLY DOSE IN FULL UNITS. (THAT IS SOMETHING THAT SHOULD BE CHANGED AS TYPE 1'S, ESPECIALLY CHILDREN, CANNOT INCREASE THEIR LANTUS DOSE BY FULL UNITS). ANYWAY, MY DAUGHTER HAS BEEN RUNNING HIGH FOR 3-4 DAYS AND I HAVE BEEN TRYING TO NARROW DOWN ALL OF THE POSSIBLE CAUSES, INCREASING HER MEALTIME INSULIN ETC BUT NOTHING WAS WORKING. WHEN SHE RUNS HIGH CONSISTENTLY, IT MAKES HER FEEL YUCKY AND MAKES ME FEEL STRESSED AND WORRIED ABOUT LONG TERM DAMAGE. IT SEEMED AS THOUGH SHE NEEDED MORE LANTUS AND WHEN I LOOKED AT THE SYRINGES I NOTICED THAT THE NEW BATCH I WAS USING FOR THE LAST FEW DAYS HAD THE FIRST HASHMARK STARTING VERY CLOSE TO THE TOP WHERE NORMALLY THERE IS MORE OF A GAP BETWEEN THE TOP OF THE SYRINGE AND THE START OF THE HASHMARKS. SO THE DOSE THAT HAS BEEN WORKING FOR HER WAS NO LONGER WORKING BECAUSE SHE WAS GETTING MAYBE 1/2 UNIT LESS THAN SHE NEEDED. FOR HER, THIS MEANT SHE WAS SPIKING INTO THE 300'S AFTER MEALS (EVEN WITH INCREASED MEALTIME INSULIN) AND WAKING UP IN THE 200'S. I AM NOT SURE WHICH MARK IS ACTUALLY CORRECT. IT SEEMS LIKE THE ONE CLOSER TO THE TOP WOULD BE MORE ACCURATE BUT AT LEAST HALF OF THE SYRINGES WE HAVE START FURTHER DOWN WHICH MAKES IT HARD FOR US TO DOSE HER CONSISTENTLY. THERE ARE ALSO OFTEN SLANTED LINES AND OR EXTRA BOLD LINES WHICH CAN MAKES THINGS TRICKY TOO. I WOULD JUST LIKE TO NOT HAVE TO STUDY THE SYRINGES BEFORE I DOSE TO DETERMINE IF SHE NEEDS 15, 15.5, 14.5 UNITS, ETC. OBVIOUSLY, THERE ARE A LOT OF FACTORS THAT CAN CAUSE HIGHS BUT THAT JUST MAKES IT EVEN MORE IMPORTANT TO HAVE SOME CONTROLLED VARIABLES SUCH AS SYRINGE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480190 SYRINGE 0.3ML 31GA 6MM HALFUNIT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 SEE H10 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other