BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21309548 · Received February 4, 2025

    Report

    Report Number
    1213809-2025-00071
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 13, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). LABEL CONTENT MISSING. TWENTY SAMPLES AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NINETEEN SAMPLES WERE RECEIVED IN SEALED PACKAGES AND ONE SAMPLE IN A CUT PACKAGE. ONE PACKAGED SYRINGE WAS FOUND TO HAVE NO DEFECTS OBSERVED AND THE CUT PACKAGE WAS FOUND THAT THE APPLICABLE PRODUCT INFORMATION WAS REMOVED, ALTHOUGH IT CANNOT BE CONFIRMED THAT THE PACKAGE WAS CUT AT THE MANUFACTURING PLANT. EIGHT PACKAGES HAVE THE VARIABLE DATA MISSING AND TEN PACKAGES THE VARIABLE DATE IS CUT-OFF ACROSS TWO DIFFERENT PACKAGES. ONE PHOTO SHOW FOUR SYRINGE PACKAGES WITH THE VARIABLE DATA MISSING ON ONE SYRINGE AND CUT-OFF ON THE OTHER THREE PACKAGES. ANOTHER PHOTO SHOWS THE PALLET LABEL, AND ONE PHOTO SHOWS THE BOX CARTON LABEL WITH ALL APPLICABLE PRODUCT INFORMATION. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING/CUT-OFF VARIABLE DATA DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THE ROOT CAUSE MOST LIKELY ATTRIBUTED TO THE UNIQUE DEVICE IDENTIFICATION (UDI) PRINTER TIMING BEING OFF DUE TO A START-UP OR SHUTDOWN OF THE PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4201650. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THIS WAS THE FIRST COMPLAINT RECEIVED FOR LABEL CONTENT MISSING WITH LOT # 4201650.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR - LABEL CONTENT MISSING. TWENTY SAMPLES AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NINETEEN SAMPLES WERE RECEIVED IN SEALED PACKAGES AND ONE SAMPLE IN A CUT PACKAGE. ONE PACKAGED SYRINGE WAS FOUND TO HAVE NO DEFECTS OBSERVED AND THE CUT PACKAGE WAS FOUND THAT THE APPLICABLE PRODUCT INFORMATION WAS REMOVED, ALTHOUGH IT CANNOT BE CONFIRMED THAT THE PACKAGE WAS CUT AT THE MANUFACTURING PLANT. EIGHT PACKAGES HAVE THE VARIABLE DATA MISSING AND TEN PACKAGES THE VARIABLE DATE IS CUT-OFF ACROSS TWO DIFFERENT PACKAGES. ONE PHOTO SHOW FOUR SYRINGE PACKAGES WITH THE VARIABLE DATA MISSING ON ONE SYRINGE AND CUT-OFF ON THE OTHER THREE PACKAGES. ANOTHER PHOTO SHOWS THE PALLET LABEL, AND ONE PHOTO SHOWS THE BOX CARTON LABEL WITH ALL APPLICABLE PRODUCT INFORMATION. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING/CUT-OFF VARIABLE DATA DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL # 309657 AND BATCH # 4201650. IT WAS REPORTED THAT THE BD LUER-LOK LABEL CONTENT WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THEY OBSERVED TO HAVE MISSING OR MISALIGNED PRINTED INFORMATION ON THE SYRINGE PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THIS MORNING, SEVERAL 309657 3ML US SYRINGES (CIA60003) FROM LOT 4201650 WERE OBSERVED TO HAVE MISSING OR MISALIGNED PRINTED INFORMATION ON THE SYRINGE PACKAGING. EIGHTEEN (18) SYRINGES WITH PRINTING ERRORS HAVE BEEN DISCOVERED SO FAR. LET ME KNOW IF YOU NEED SOME OF THESE SYRINGES RETURNED TO YOU FOR ASSESSMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246251 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4201650 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown