BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL BNS

    MDR report key: 20712107 · Received November 18, 2024

    Report

    Report Number
    1213809-2024-00849
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 10, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903096485
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIFTY-SEVEN SAMPLES AND FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE RECEIVED LOOSE WITH BROWNISH DISCOLORATIONS ON ALL THE BARRELS AREA CONSISTENT WITH EMBEDDED FOREIGN MATTER. TWO PHOTOS SHOW LOOSE SYRINGES WITH THE BROWNISH DISCOLORATION ON THE BARRELS. TWO PHOTOS SHOW EACH LOOSE BARRELS WITH THE PLUNGER AND STOPPER MISSING. THE CONDITION OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. POTENTIAL ROOT CAUSE FOR THE PLUNGER ROD MISSING DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY, SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4123603. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE PROCESSING OF AN ORDER, WE IDENTIFIED 57 CONTAMINATED SYRINGES (MATERIAL 300043766 - BATCH 4123603). FURTHERMORE, WITHIN THE SAME BATCH AND MATERIAL, WE FOUND 51 SYRINGES MISSING RODS (PLEASE SEE PICTURES BELOW). MAT: 300043766. VENDOR MATERIAL NO: 309628. SYRINGE, LL, TB,3-PART, 1CC. BATCH: 4123603. TRACKWISE REFERENCE NUMBER: PR #(B)(4). PLEASE INVESTIGATE WHY THIS ISSUE OCCURRED IN THE ABOVE BATCH AND PLEASE PROVIDE US CORRECTIVE ACTIONS. THANK YOU FOR YOUR SUPPORT AND PLEASE REACH OUT IF YOU NEED MORE INFORMATION. ADDITIONAL INFORMATION PROVIDED: I APOLOGIZE¿I HAVE SENT YOU THE VENDOR CODE FOR THE STERILE VERSION OF THE SYRINGES. THE CORRECT VENDOR MATERIAL NUMBER IS 309648, AND THE BATCH NUMBER IS 4123603.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604457 BD SYRINGE 1ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4123603 50382903096485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown