BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 25GA 3/4IN W/O SILICONE

    MDR report key: 9713876 · Received February 14, 2020

    Report

    Report Number
    1911916-2020-00149
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 11, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED. IT SHOWS ONE PLASTIC BAG WITH PRODUCTS INSIDE AND NO LABEL. IT IS LIKELY THAT WHEN PACKAGING THE BULK PRODUCT AND THE BAG WAS FULL, IT WAS SEALED BUT NOT LABELED AND NOT DETECTED IN THE NEXT PROCESSES. 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 1ST COMPLAINT FOR LOT # 9130640 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE NS 25GA 3/4IN W/O SILICONE EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 301670 BATCH NO: 9130640. IT WAS REPORTED THAT A BAG WAS FOUND TO BE UNLABELED DURING VISUAL INSPECTIONS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: DATE OF INCIDENT: (B)(6) 2020. PART NO.: 05-8016 (300030259). BATCH NO.: 9130640. QTY IMPACTED: 1 BAG. DESCRIPTION OF COMPLAINT: INCOMING INSPECTOR FOUND AN UNLABELED BAG WHILE PULLING SAMPLES FOR VISUAL INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178124 NEEDLE NS 25GA 3/4IN W/O SILICONE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9130640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other