BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER

    MDR report key: 13045858 · Received December 20, 2021

    Report

    Report Number
    3014704491-2021-00364
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Date of Event
    November 15, 2021
    Report Date
    December 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231208. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER, THE DEVICE EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AFTER THE PUNCTURE WAS SUCCESSFUL, THE JOINT WAS TIGHTENED AND THE PATIENT'S SHEETS WERE FOUND TO BE WET AT 9:00. LATER, IT WAS FOUND THAT THERE WAS FLUID LEAKAGE AT THE JOINT OF THE PATIENT'S VENOUS INDWELLING NEEDLE, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED WITH A RE-PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945886 BD INTIMA II¿ IV CATHETER WITH PRN ADAPTER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0231208

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown