BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8453365 · Received March 26, 2019

    Report

    Report Number
    3006948883-2019-00213
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 5, 2019
    Report Date
    April 8, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8080269. 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. 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 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BROKE DURING INJECTION AND THE DRUG LEAKED. VERBATIM: "NURSE FEEDBACK CATHETER BROKEN DURING INJECTION OF ENHANCING DRUG, DRUG LEAKED INTO TISSUE, LEADING TO ENHANCE CT FAILURE, SWELLING OF LIMBS, COMPRESS WITH DEXAMETHASONE, LIMB ELEVATION TREATMENT. MD REGISTRATION CERTIFICATE#(B)(4)."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BROKE DURING INJECTION AND THE DRUG LEAKED. VERBATIM: "NURSE FEEDBACK CATHETER BROKEN DURING INJECTION OF ENHANCING DRUG, DRUG LEAKED INTO TISSUE, LEADING TO ENHANCE CT FAILURE, SWELLING OF LIMBS, COMPRESS WITH DEXAMETHASONE, LIMB ELEVATION TREATMENT. MD REGISTRATION CERTIFICATE# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247415 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 8080269

    Patients

    Seq Age Sex Outcome Treatment
    0 Required Intervention