BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 18188696 · Received November 21, 2023

    Report

    Report Number
    1213809-2023-01329
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 11, 2023
    Report Date
    February 17, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010290
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED A HAIR WAS FOUND IN THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE AND ONE PHOTO OF A 10ML LUER LOK SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE WAS RECEIVED IN AN UNSEALED BD PACKAGE AND HAS A 1-1/2" BLACK HAIR INSIDE THE FLUID PATH THAT EXTENDS PAST THE STOPPER INTO THE NON-FLUID PATH. THE PHOTO SHOWS THE SYRINGE IN THE PACKAGE WITH A THIN BLACK LINE IN THE NON-SCALE MARKING AREA AT THE ROOF OF THE BARREL. FROM THE PHOTO, WE ARE NOT ABLE TO DETERMINE WHAT THE BLACK LINE IS. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED, AND THE FOREIGN MATTER WAS MOST LIKELY HUMAN HAIR. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301039, LOT 3122543. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3122543 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE REPORTED DEFECT WAS MANUFACTURED IN THE HOLDREGE PLANT WHICH NO LONGER MANUFACTURES THIS PRODUCT. THEREFORE, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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 THE BD SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HAIR FOUND IN A 10CC SYRINGE." SUPPLIER PRODUCT DESCRIPTION: SYRINGE 10CC L/L NO CAPS LOT #: 3122543. SAMPLE AVAILABLE? NO. SUPPLIER PRODUCT # 301029.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745156 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3122543 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown