BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE CATHETER TIP 50ML

    MDR report key: 21220516 · Received January 23, 2025

    Report

    Report Number
    1911916-2025-00044
    Event Type
    Malfunction
    Date Received
    January 23, 2025
    Date of Event
    November 14, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    KYZ
    UDI-DI
    30382903096207
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE CATHETER TIP IS CONTAMINATED WITH A FOREIGN MATERIAL. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE PLASTIC CAP HAS EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309620, LOT 4172759. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED

    Description of Event or Problem · 0

    MATERIAL#: 309620. BATCH#: 4172759. VERBATIM: CONCERN DESCRIPTION: CATHETER TIP IS CONTAMINATED WITH FOREIGN MATERIAL. ADDITIONAL INFORMATION NO; THE CONTAMINATION WAS DETECTED BEFORE THE PRODUCT WAS OPENED AND WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420407 SYRINGE CATHETER TIP 50ML SYRINGE, IRRIGATING (NON DENTAL) KYZ BECTON DICKINSON 4172759 30382903096207

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown