BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 1/2IN 90 BX 450 MO

    MDR report key: 11944589 · Received June 6, 2021

    Report

    Report Number
    1920898-2021-00640
    Event Type
    Malfunction
    Date Received
    June 6, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282791
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. INVESTIGATION CONCLUSION: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 0090937 FOR DIFFICULT/UNABLE TO OPERATE (NOT DRAWING). THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE (NOT DRAWING) ON LOT # 0090937. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 1/2IN 90 BX 450 MO WAS UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328279 BATCH NO: 0090937. CALLER REPORTED FILL RESISTANCE ISSUE. CUSTOMER'S BG AT TIME OF EVENT - [121 MG/DL] ; BETWEEN 54-500 MG/DL (3.0-27.7 MMOL/L), NO FURTHER BG QUESTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841189 SYRINGE 0.5ML 1/2IN 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328279 0090937 00382903282791

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR