BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 30X1/2 RB

    MDR report key: 9505591 · Received December 20, 2019

    Report

    Report Number
    1911916-2019-01318
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    June 27, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RECEIVED; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THEREFORE, A POTENTIAL ROOT CAUSE(S) CANNOT BE DETERMINED. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER FOR LOT #8090554 ITEM #305106. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THEREFORE, A POTENTIAL ROOT CAUSE(S) CANNOT BE DETERMINED. RATIONALE: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD¿ NEEDLE 30X1/2 RB HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE HAD FUZZ ON OR IN IT PRIOR TO USE. PER EMAIL: ON 1-JUL-2019, THE REPORTER CONTACTED DISTRIBUTOR VIA PHONE TO REQUEST REPLACEMENT OF EYLEA VIAL(S). THE REPORTER DENIED ANY MISSED DOSES OR ADVERSE EVENTS ASSOCIATED WITH THIS REQUEST. THE PATIENT SUCCESSFULLY RECEIVED A DOSE FROM A NEW EYLEA KIT. ON (B)(6) 2019 PRIOR TO ADMINISTRATION, THE ADMINISTRATION NEEDLE WAS NOTED TO HAVE FUZZ ON OR IN THE NEEDLE SO WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302534 BD¿ NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8090554 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other