BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1 RB

    MDR report key: 8359230 · Received February 21, 2019

    Report

    Report Number
    1911916-2019-00209
    Event Type
    Malfunction
    Date Received
    February 21, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051250
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    500 SAMPLES AND 2 PHOTOS WERE RECEIVED FOR EVALUATION. THE SHELF BOX IS LABELED AS 305125- 25G X 1; THE PRODUCTS INSIDE HAVE THE TOP WEB AS 305122 ¿ 25G X 5/8. THE ACTUAL PRODUCTS ARE 25 X 1. THE TOP WEB IS INCORRECT. THE PHOTOS SHOW THE DESCRIBED DEFECT, THEREFORE FAILURE MODE IS VERIFIED. PROBABLE ROOT CAUSE WAS AN INCORRECT REWORK. THE SHELF BOX LABEL WAS INITIALLY CREATED WITH THE INCORRECT LINEAR BARCODE. A QUALITY NOTIFICATION WAS ISSUED AND THE SHELF BOX LABEL REWORKED. DURING THE REWORK, THE INCORRECT TOP WEB WAS USED, CAUSING THE REPORTED FAILURE MODE. THE PRODUCT REMAINS ON HOLD UNTIL FURTHER NOTICE. A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) 760699 HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE. 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. THERE WAS DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH # 8088580 DURING THIS PRODUCTION RUN. THE LOT# WAS NOT PROPERLY PRINTED. A QN WAS ISSUED. SHELF BOX LABEL REWORKED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLES 25X1 RB EXPERIENCED INCORRECT LABEL INFORMATION WITH THE ITEM NUMBER ON THE INSIDE OF THE BOX NOT MATCHING THE ACTUAL ITEM NUMBER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLES 25X1 RB EXPERIENCED INCORRECT LABEL INFORMATION WITH THE ITEM NUMBER ON THE INSIDE OF THE BOX NOT MATCHING THE ACTUAL ITEM NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150257 NEEDLE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903051250

    Patients

    Seq Age Sex Outcome Treatment
    1 Other