BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13839034 · Received March 21, 2022

    Report

    Report Number
    3014704491-2022-00104
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 17, 2022
    Report Date
    March 22, 2022
    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

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1203278. 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. ADDITIONALLY, A PHOTOGRAPH OF THE AFFECTED DEVICE WAS SUBMITTED, WHICH DISPLAYED DAMAGE TO THE SLEEVE STOPPER OF THE ADAPTER. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT FROM THE PHOTOGRAPH ALONE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS PRN WAS FOUND DAMAGED WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT 15:55 P.M. ON (B)(6) 2022, THE NURSE OF THE DEPARTMENT OF INFECTION PREPARED TO INSERT NEEDLES FOR THE CHILDREN, OPENED THE PACKAGE OF AN ENCLOSED VENOUS INDIGNANT NEEDLE, AND FOUND THAT THE PRN OF THE INDIGNANT NEEDLE WAS DAMAGED, SO IT WAS ABANDONED AND SEALED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS PRN WAS FOUND DAMAGED WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT 15:55 P.M. ON FEBRUARY 17, 2022, THE NURSE OF THE DEPARTMENT OF INFECTION PREPARED TO INSERT NEEDLES FOR THE CHILDREN, OPENED THE PACKAGE OF AN ENCLOSED VENOUS INDIGNANT NEEDLE, AND FOUND THAT THE PRN OF THE INDIGNANT NEEDLE WAS DAMAGED, SO IT WAS ABANDONED AND SEALED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517761 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1203278

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown