BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7361582 · Received March 22, 2018

    Report

    Report Number
    1920898-2018-00172
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT THE FIRST SCALE MARKS ARE TILTED TO THE SIDE, IT'S DIFFICULT TO MEASURE THE INSULIN DOSE CORRECTLY, AND HER DOG HAS EXPERIENCED HYPOGLYCEMIC EPISODE MULTIPLE TIMES, BUT NO MEDICAL TREATMENT REQUIRED. BOTH RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND THE PLACEMENT OF ALL SCALE MARKINGS FELL WITHIN SPECIFICATIONS. SEE ATTACHED PHOTOS. AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7023681 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200683642] NOTED FOR A PRINT DEFECT. THERE WERE FIVE (5) NOTIFICATIONS [200683983, 200683822, 200683642, 200683852, 200683853] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SCALE MARKING PLACEMENT AND HYPOGLYCEMIA). 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 INVESTIGATION CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT THE SCALE MARKINGS OF THE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WERE TILTED CAUSING HYPOGLYCEMIC EPISODE MULTIPLE TIMES IN HER DOG, NO MEDICAL INTERVENTION OR TREATMENT NEEDED. FOUND AFTER USE. NO REPORTS OF SERIOUS INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203652 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7023681

    Patients

    Seq Age Sex Outcome Treatment
    1 Other