BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 20779333 · Received November 26, 2024

    Report

    Report Number
    1911916-2024-00846
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 13, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    00382903065950
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WITH DEVICE EVALUATION. IT WAS REPORTED THERE WAS A BLACK FOREIGN OBJECT AT THE TAPERED END OF THE CONSUMABLE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING FLOW WRAP. THE SYRINGE BARREL HAS A DARK STAIN AT THE BOTTOM OF THE LUER. FROM THE PHOTO, IT IS NOT POSSIBLE TO CONFIRM WHETHER IT IS EMBEDDED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306595, LOT 4152257. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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

    THE NURSE IS FOLLOWING THE DOCTOR'S ORDERS TO ADMINISTER FLUIDS TO A PATIENT. OPENS A BRAND NEW PREFILLED CATHETER FLOSSER AND DISCOVERS A BLACK FOREIGN OBJECT AT THE TAPERED END OF THE CONSUMABLE; IMMEDIATELY STOPS THE OPERATION AND REPLACES IT WITH A NEW PREFILLED CATHETER FLOSSER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434314 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 4152257 00382903065950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown