BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II PLUS¿ IV CATHETER

    MDR report key: 15642636 · Received October 20, 2022

    Report

    Report Number
    3014704491-2022-00500
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    August 6, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830558
    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

    INITIAL REPORTER E-MAIL: UNKNOWN. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111433. 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 THAT THE BD INTIMA II PLUS¿ IV CATHETER WAS FOUND TO BE SPLIT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (CHINESE: "DUE TO 38+1 WEEKS OF INTRAUTERINE PREGNANCY AND ELEVATED BLOOD PRESSURE FOR 1 WEEK, SHE WAS ADMITTED TO THE DEPARTMENT OF GYNECOLOGY OF THE HOSPITAL ON (B)(6) 2022. THE PATIENT WAS ADMITTED FOR PHYSICAL EXAMINATION AND WAS DIAGNOSED WITH GESTATIONAL HYPERTENSION AT 38+1 WEEKS OF GESTATION. THE PATIENT UNDERWENT LOWER UTERINE CESAREAN SECTION IN THE OPERATING ROOM ON (B)(6) 2022, AND THE INTRAVENOUS INDWELLING NEEDLE WAS USED. DURING THE USE, THE INTRAVENOUS INDWELLING NEEDLE HOSE APPEARED BIFURCATION, AND THERE WAS RESISTANCE IN THE BLOOD VESSEL. STOP USING IMMEDIATELY. ANOTHER VENOUS INDWELLING NEEDLE WAS REPLACED AND USED NORMALLY, CAUSING A SECOND PUNCTURE TO THE PATIENT. THE HOSPITAL CLEARLY REPLIED THAT THE USE OF OUR PRODUCTS WAS CAUSED BY THE OPERATION OF HOSPITAL STAFF AND DID NOT BRING ADVERSE EFFECTS TO THE PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987099 BD INTIMA II PLUS¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1111433 00382903830558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown