BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24916207 · Received April 17, 2026

    Report

    Report Number
    1213809-2026-00209
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - LABEL CONTENT INCORRECT. TWO PHOTOGRAPHS OF 5 ML LUER LOK SYRINGES (PART NUMBER 309646) WERE RECEIVED AND EVALUATED. THE FIRST IMAGE SHOWS THE TOP WEB SLIP WITH COMPLETE AND ACCURATE PRODUCT INFORMATION, INCLUDING AN EXPIRATION DATE OF 2030-05-31, WHILE THE SECOND IMAGE SHOWS A BOX LABEL DISPLAYING AN INCORRECT EXPIRATION DATE OF 2030-04-30, INDICATING A DISCREPANCY BETWEEN PACKAGING COMPONENTS AND NONCONFORMANCE TO SPECIFICATIONS. AS PART OF THE INVESTIGATION, INTERVIEWS WITH CONTROLS PERSONNEL WERE CONDUCTED, ALONG WITH A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR), PRODUCTION DATABASE, AND ASSOCIATED ELECTRICAL AND MECHANICAL RECORDS, WHICH IDENTIFIED A CONDITION LINKED TO THE DEFECT THAT WAS NOT DETECTED DURING MANUFACTURING. THE MOST PROBABLE ROOT CAUSE IS ASSOCIATED WITH THE PACKAGING PROCESS, AND CORRECTIVE ACTIONS WILL BE IMPLEMENTED, INCLUDING ISSUING A QUALITY ALERT TO THE PLANT AND UPGRADING THE SYSTEM TO PREVENT RECURRENCE. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. THIS INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY, AND OUR BUSINESS TEAM WILL REGULARLY REVIEW THE COLLECTED DATA TO IDENTIFY ANY EMERGING TRENDS.

    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

    IT WAS REPORTED THAT BD SYRINGE 5ML LL SP125 LABEL CONTENT INCORRECT. COMPLAINT VIA EMAIL. MY NAME IS XXXX AND WE PROCURE YOUR BD 5ML SYRINGES THROUGH A SUPPLIER CALLED XXXXXXX. WE'VE RECENTLY ENCOUNTERED AN ISSUE WHERE THE EXPIRY DATE ON THE BOX DOES NOT MATCH THE EXPIRY DATE ON INDIVIDUAL PACKAGED SYRINGES. THE BOX EXPIRY DATE IS 2030-04-30 WHILE EACH INDIVIDUAL UNIT HAS AN EXPIRY DATE OF 2030-05-31. THIS IS CAUSING A CONFUSION WITHIN OUR MANUFACTURING PROCESS AND WE WOULD LIKE TO UNDERSTAND IF THIS IS AN ACTUAL DEFECT OR IF THERE IS AN EXPLANATION FOR THE EXPIRY DATE MISMATCH. WE HAVE CONFIRMED 11 FULL BOXES OF LOT: 5154045 TO BE AFFECTED. WE WOULD LIKE TO OPEN A DISCUSSION AND GET THIS RESOLVED AS SOON AS POSSIBLE. OUR SUPPLIER WAS NOTIFIED BUT NO RESPONSE WAS PROVIDED SO WE ARE HOPING THE MANUFACTURING SITE (BD) CAN PROVIDE A RESPONSE INSTEAD. PRODUCT NAME AND/OR CATALOG NUMBER: BD LUER-LOK SYRINGE STERILE, SINGLE USE, 5 ML LOT NUMBER OR SERIAL NUMBER: LOT: 5154045, REF 309646. ANY INJURIES AND/OR HARM? N/A. WHAT IS THE ISSUE YOU EXPERIENCED? EXPIRY DATE MISMATCH FROM BOX AND INDIVIDUAL UNIT. IS THE ACTUAL SAMPLE OR SAMPLE REPRESENTATIVE AVAILABLE? (IF POSSIBLE, PLEASE SEND AFFECTED SAMPLE) YES, ALL 11 BOXES ARE AVAILABLE. CONTACT NAME AND PHONE NUMBER: X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254062 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5154045 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1