BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II PRN

    MDR report key: 12914565 · Received December 2, 2021

    Report

    Report Number
    3014704491-2021-00314
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    October 16, 2021
    Report Date
    November 12, 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 BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050858. 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 PRN, THE DEVICE EXPERIENCED LEAKAGE DUE TO A LOOSE PRN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON THE MORNING OF OCTOBER 16, THE NURSE REPLACED THE NEEDLE FOR INFUSION, AND THE BLOOD RETURN COULD BE SEEN AFTER PUNCTURING. AND THE TAPE WAS STICKED, THE LEAKAGE WAS FOUND AT INFUSION SITE HALF AN HOUR LATER. IT WAS FOUND THAT THE PRN CAN'T BE TIGHTEN AFTER CHECKING, AFTER REPLACEMENT, THE PRN IS STILL UNABLE TO TIGHTEN, ONLY TO PULL AND REPLACE THE NEEDLE AGAIN, AND THERE WAS NO PRESENT ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813687 BD INTIMA-II PRN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1020972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown