BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SAF-T-INTIMA¿ CLOSED IV CATHETER

    MDR report key: 8401528 · Received March 7, 2019

    Report

    Report Number
    3006948883-2019-00165
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 1, 2019
    Report Date
    March 28, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233359. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF LEAKAGE OCCURRING IN THIS BATCH OF INTIMA II. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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 THAT DURING USE OF THE UNSPECIFIED BD SAF-T-INTIMA¿ CLOSED IV CATHETER FOUND LIQUID LEAKAGE AT NEEDLE POINT, NO REDNESS AND SWELLING IN THE NEEDLE EYE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE UNSPECIFIED BD SAF-T-INTIMA¿ CLOSED IV CATHETER FOUND LIQUID LEAKAGE AT NEEDLE POINT, NO REDNESS AND SWELLING IN THE NEEDLE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195446 UNSPECIFIED BD SAF-T-INTIMA¿ CLOSED IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233359

    Patients

    Seq Age Sex Outcome Treatment
    1 Other