BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG

    MDR report key: 9280148 · Received November 5, 2019

    Report

    Report Number
    1920898-2019-01246
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 18, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION; COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S1; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE HUB SEPARATES ON LOT # 9042880. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042880. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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. 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 AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 0.5ML 31GA 8MM 10 BAG HAS BEEN FOUND EXPERIENCING NINE OCCURRENCES OF THE HUB SEPARATING FROM THE DEVICE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE HUBS SEPARATED AND STAYED IN THE SHIELD. VERBATIM: FROM PHONE CALL ON 2019-10-21 16:32:54: UPDATE- CONSUMER CALLED BACK WITH PHARMACY INFORMATION FOR REPLACEMENTS TO BE SENT TOO. THE TOTAL AMOUNT FOUND IN THIS BOX IS 5 FROM ONE BAG AND 4 FROM A 2ND BAG ALL WITH NEEDLE HUBS STAYED WITHIN THE NEEDLE SHIELDS. SPOUSE OF CONSUMER REPORTED 5 NEEDLE HUBS SEPARATED AND STAYED IN THE SHIELD, INSIDE OF THE SEALED BAG. SAMPLES WERE DISCARDED. LOT # 9042880, PRODUCT # 328509, NO EXP DATE, OCCURRENCE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070978 SYRINGE 0.5ML 31GA 8MM 10 BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9042880 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other