BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 20413264 · Received October 9, 2024

    Report

    Report Number
    1213809-2024-00693
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    September 16, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT SYRINGE HAS BROWNISH DISCOLORATION ON THE BARREL CONSISTENT WITH EMBEDDED FOREIGN MATTER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER EMBEDDED DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THIS CONDITION IS 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 4123156. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    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

    MATERIAL#: 309646; BATCH NUMBER#: 4123156. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: THIS NEEDS TO BE TAKEN TO THE ATTENTION OF BD IMMEDIATELY. I DON¿T HAVE THE REP'S CONTACT. TODAY, (B)(4), COPIED HERE, FROM THE CATH LAB HAD TWO SEPARATE MAJOR FLAWS WITH BD SYRINGES. THE FIRST WAS A 5ML LUER LOK SYRINGE THAT WAS OPENED TODAY AND HAD SOME SORT OF STAIN ON THE END. ALSO, THEY HAD A PLASTIPAK 3ML SYRINGE THAT WAS THE PACKAGE ONLY- THERE WAS NO ITEM IN THE PACKAGE. IT WAS SEALED AND EVERYTHING BUT NO SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956281 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4123156 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown