BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 22582847 · Received July 23, 2025

    Report

    Report Number
    1213809-2025-00495
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    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) - SUPPLEMENTAL MDR - BARREL CRACKED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL EURO 200 S/C BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS MORNING WE OBSERVED TWO CRACKS IN BD 3ML LL SYRINGES:: ONE CAUSED THE SYRINGE TO BREAK WHILE PREPARING A CYTOTOXIC DRUG. THE OTHER CRACK WAS NOTICED BY A NURSE AFTER ADMINISTERING A CYTOTOXIC DRUG SC --> A DROP APPEARED OUTSIDE THE SYRINGE. THE BATCHES THAT MAY BE AFFECTED ARE: 5024932; 4352797; 4352796; 3073041. AS THE SYRINGES CONTAINED CYTOTOXIC PRODUCTS, WE DID NOT KEEP THEM. 10-JUL-2025 - ADDITIONAL INFORMATION RECEIVED REFERENCE NUMBER: 309658.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604533 PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4352797 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown