BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML ALLERGIST TRAY W/ BD SAFETYGLIDE NEEDLE

    MDR report key: 8620280 · Received May 17, 2019

    Report

    Report Number
    1920898-2019-00466
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 6, 2019
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 REPORTED WITH THE DEFECT/CONDITION OF TIP CAP MISSING WITH LOT #8143662 REGARDING ITEM #305950. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 # 8143662 CAP MISSING. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) 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 WAS REPORTED THAT 1 ML ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE CAME WITH A BOX OF SYRINGES AND 1 SYRINGE WAS MISSING A CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305950. BATCH/LOT: 8143662. IT WAS REPORTED THAT THE BOX OF SYRINGES HAD 1 SYRINGE WITHOUT A CAP. CUSTOMER TEXT: PER CUSTOMER, WAS RESTOCKING THE DRAWER AND THAT PARTICULAR BOX OF SYRINGES HAD 1 SYRINGE WITHOUT A CAP. THERE WAS NOT A LOSE CAP IN THE BOX EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415270 1 ML ALLERGIST TRAY W/ BD SAFETYGLIDE NEEDLE SYRINGE W/ NEEDLE FMF BD MEDICAL - DIABETES CARE 8143662 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other