BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8488261 · Received April 5, 2019

    Report

    Report Number
    1911916-2019-00356
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO (2) PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. ONE PHOTO APPEARS TO SHOW A FAINT LINE IN THE SYRINGE INDICATING A POSSIBLE FIBER IN THE SYRINGE. HOWEVER, WITHOUT A PHYSICAL SAMPLE TO ANALYZE THE COMPOSITION OF THE FIBER BE DETERMINED. THE SECOND PHOTO SHOWS A SYRINGE BARRELS WITH BLACK SPOTS ON IT ALONG WITH A PIECE OF WHAT APPEARS TO BE TAPE. IT ALSO APPEARS THAT THE BLACK SPOTS ARE ON THE TAPE. WITHOUT A SAMPLE TO ANALYZE IT CANNOT BE DETERMINED IF THE BLACK SPOTS ARE LOOSE OR EMBEDDED AND THE ROOT CAUSE CANNOT BE DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION (BATCH 8023808). THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HAIR WAS FOUND IN THE BD¿ LUER-LOK SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS HAIR FOUND INSIDE THE SYRINGES."

    Additional Manufacturer Narrative · 1

    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 A HAIR WAS FOUND IN THE BD¿ LUER-LOK SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS HAIR FOUND INSIDE THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282696 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8023808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other