BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 23815629 · Received December 16, 2025

    Report

    Report Number
    1213809-2025-00783
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    August 4, 2025
    Report Date
    April 21, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096589
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST
    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

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. BATCH 2012741 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THE COMPLAINT WAS NOT CONFIRMED, AND NO CAPA EVALUATION WAS REQUIRED PER GPR-10033. THIS COMPLAINT TYPE WILL CONTINUE TO BE TRENDED WITHIN THE POST-MARKET SURVEILLANCE PROCESS, AND ANY DETERMINED ESCALATION WILL BE MANAGED THERE.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ONE SUBJECT TREATED WITH A SYRINGE OF THIS BATCH HAD AN INJECTION REACTION (SAE). ADDITIONAL INFORMATION PROVIDED: · COULD YOU CONFIRM ABOUT THE APPLIED TREATMENT: HOW WAS THE REPORTED SITE REACTION AT THE INJECTION SITE TREATED? · SITE REACTION OCCURRED BETWEEN FOLLOW UP VISITS OF THE PATIENT APPROX. 10 DAYS AFTER INJECTION. THIS LED TO MEDICAL TREATMENT AT THE EMERGENCY ROOM AND ANTI-INFLAMMATORY TREATMENT WITH ANTIBIOTICS. · COULD YOU CONFIRM ¿A PATIENT WHO WAS TREATED WITH A SYRINGE FROM THIS BATCH HAD A SERIOUS ADVERSE EVENT (SAE). THE INCIDENT WAS A SITE REACTION AT THE INJECTION SITE¿. WHAT IS MEANT BY ¿SITE REACTION¿. PATIENT DEVELOPED AN IATROGENIC SUBCUTANEOUS ABSCESS IN THE AREA OF THE INJECTION SITE AND LOCAL INFLAMMATION. · ANY MEDICAL INTERVENTION REQUIRED AS A RESULT? EMERGENCY DRAINING OF THE ABSCESS AND ANTIBIOTICAL TREATMENT. SKIN TRANSPLANTATION DUE TO IMPAIRED WOUND HEALING NECESSARY. WAS ANYTHING UNUSUAL NOTED WITH THE SYRINGE? NOTHING UNUSUAL WAS NOTED WITH THE SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620948 PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2012741 00382903096589

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other