BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 9970329 · Received April 16, 2020

    Report

    Report Number
    1911916-2020-00387
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    April 3, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. IT SHOWS A NEEDLE ASSEMBLY, THE PLASTIC SHIELD HAS BEEN PARTIALLY REMOVED SHOWING THE BOTTOM PART OF THE NEEDLE WHERE THE JOIN TO THE PLASTIC HUB IS. THE WHITE EPOXY IS OBSERVED. THE WHITE EPOXY HAS A DRIP OVER THE CANNULA. 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: THIS IS THE 3RD COMPLAINT FOR LOT # 7200624 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: UNDETERMINED. THE MAX ALLOWED OF EPOXY OVER THE CANNULA IS 1/8¿. BASED ON THE PHOTO THIS SAMPLE LOOKS ACCEPTABLE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLES FILTER BLUNT FILL 18X1-1/2 EXPERIENCED FOREIGN MATTER IN OR ON DEVICE CANNULA/NEEDLE/CORING. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO INFORM YOU OF A COMPLAINT FROM A KOREAN COSTUMER CONCERNING THE ABOVE STATED EYLEA FILTER NEEDLE. IT WAS REPORTED THAT THERE WAS A WHITE FOREIGN PARTICLE ON THE SURFACE OF THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434093 NEEDLE FILTER BLUNT FILL 18X1-1/2 MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 7200624 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other