BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 100 BX 1200 LA

    MDR report key: 10222133 · Received July 1, 2020

    Report

    Report Number
    9616656-2020-00619
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. (B)(4). INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST. RELATED COMPLAINT FOR LEAKAGE ON LOT # 8122805. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4) REVISION 18, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, LEAKAGE) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. 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 WAS REPORTED THAT PEN NDL 31GA 5MM 100 BX 1200 LA LEAKED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DROPS FALL BETWEEN THE NEEDLE AND THE THREAD PART (HUB) WHEN APPLYING THE MEDICATION (SAXENDA LIRAGLUTIDE) - LEAKAGE BETWEEN THE INNER SHIELD AND THE NEEDLE. DURING A CALL WITH CUSTOMER, IT WAS IDENTIFIED HE WAS NOT REMOVING THE LILAC PROTECTOR (INNER SHIELD) IN ORDER TO EXPOSE THE NEEDLE AND PERFORM THE MEDICINE APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680399 PEN NDL 31GA 5MM 100 BX 1200 LA PEN NEEDLE FMI BECTON DICKINSON AND CO. 8122805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other