BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22475805 · Received July 10, 2025

    Report

    Report Number
    1213809-2025-00462
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 16, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096954
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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). FOLLOW UP FOR DEVICE EVALUATION TWENTY-FIVE SAMPLES AND ONE PHOTO OF 10 ML CONTROL SYRINGES (PART NUMBER 309695) FROM BATCH 5121447 WERE RECEIVED AND EVALUATED. TWENTY-ONE SYRINGES WERE FOUND ACCEPTABLE WITH NO DEFECTS OBSERVED. FOUR SYRINGES EXHIBITED BLACK DISCOLORATION ACROSS THE BOTTOM WEB; TWO ALSO HAD LARGE HOLES IN THE WEB, ONE HAD AN OPEN SEAL GREATER THAN ¼ INCH, AND ONE REMAINED SEALED. THE PHOTO CONFIRMED THE PRESENCE OF BLACK DISCOLORATION ON THE AFFECTED PACKAGES. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE OF THE PACKAGING DAMAGE AND FOREIGN MATTER DEFECTS IS ASSOCIATED WITH THE PACKAGING PROCESS. INTERVIEWS WITH PRODUCTION PERSONNEL, ALONG WITH A REVIEW OF TECHNICAL AND ELECTRICAL RECORDS AND THE PRODUCTION DATABASE, REVEALED FLUCTUATIONS IN SEAL TEMPERATURE, WHICH MAY HAVE CONTRIBUTED TO THE OBSERVED DEFECTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5121447. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE CONTROL 10ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309695, LOT#: 5121447. IT WAS REPORTED BY CUSTOMER THAT ITEM IS BUSTED OPEN INSIDE THE INDIVIDUAL PLASTIC BAGS. RCC RECEIVED A COMPLAINT VIA EMAIL. INJURIES OR ADVERSE EVENT: NO. ITEM: 309695, QUANTITY AFFECTED: 1 BX, SERIAL/LOT NUMBER: (B)(6), PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: ITEM IS BUSTED OPEN INSIDE THE INDIVIDUAL PLASTIC BAGS. SHIPPING BOXES ARE NOT DAMAGED AND IT IS ONLY SOME OF THE SYRINGES. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER RESPONSE ON (B)(6) 2025. THIS ISSUE WAS DISCOVERED ON (B)(6) 2025. AS FOR HOW MANY WERE AFFECTED, MAYBE 5 BUT I WAS UNCOMFORTABLE USING ANYTHING FROM THAT BOX SO I REPLACED ALL OF THEM AND SEALED IT SHUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894851 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5121447 00382903096954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown