BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILTER NEEDLE

    MDR report key: 8169314 · Received December 17, 2018

    Report

    Report Number
    1911916-2018-00760
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    November 30, 2018
    Report Date
    February 1, 2019
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 80 SAMPLES WERE RECEIVED FOR EVALUATION. DHR SHOWS THERE WAS DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH # 8173917 DURING THIS PRODUCTION RUN. INVESTIGATION CONCLUSION: ON 9/30/2018 THIRD SHIFT EXPERIENCED ISSUES WITH THE CROSSCUT BLADES (IMPROPER SLITS). THE 80 SAMPLES RECEIVED SHOW SIMILAR ISSUE AS THE PHOTO PROVIDED WHERE THE EXPIRATION DATE WAS CUT ABOUT 30 TO 50%. THESE ARE ESCAPES FROM THE INCIDENT EXPERIENCED. FAILURE MODE WAS VERIFIED. THE MACHINERY WAS ADJUSTED AND THE ISSUE RESOLVED. RATIONALE: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ BLUNT FILTER NEEDLE EXPIRY DATE OF SOME BLISTERS IS CUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ BLUNT FILTER NEEDLE EXPIRY DATE OF SOME BLISTERS IS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1011032 BD¿ BLUNT FILTER NEEDLE NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173917 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other