BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ ATTACHED NEEDLE

    MDR report key: 7186105 · Received January 12, 2018

    Report

    Report Number
    1920898-2017-00432
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 19, 2017
    Report Date
    February 1, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS PER MANUFACTURING, A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7072570. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THIS COMPLAINT SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF OTHER WITH LOT #7072570 REGARDING ITEM #305950. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. CONCLUSION: THE ROOT CAUSE FOR THE REPORTED FAILURE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BARREL OF THE 1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ PERMANENTLY ATTACHED NEEDLE, HAD ¿EXTRA SPACE¿ AND ALLOWED THE USER TO OVERDRAW SERUM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30811 1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ ATTACHED NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7072570 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other