BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK SYRINGE

    MDR report key: 8499578 · Received April 10, 2019

    Report

    Report Number
    1911916-2019-00366
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 18, 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: ONE (1) PHOTO WAS RECEIVED BY OUR QUALITY TEAM. THE 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 CAN'T BE DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. WITHOUT A PHYSICAL SAMPLE TO ANALYZE THE FOREIGN MATTER (FM) THAT APPEARS TO BE IN THE SYRINGE CANNOT BE IDENTIFIED; THEREFORE, POTENTIAL ROOT CAUSES CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ LUER LOK SYRINGE THERE WAS A HAIR INSIDE A SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301035 BATCH NO. 8023808. "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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD¿ LUER LOK SYRINGE THERE WAS A HAIR INSIDE A SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301035, BATCH NO. 8023808. "IT WAS REPORTED THAT THERE WAS HAIR FOUND INSIDE THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295449 BD LUER LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8023808

    Patients

    Seq Age Sex Outcome Treatment
    1 Other