BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 10687627 · Received October 15, 2020

    Report

    Report Number
    3006948883-2020-00565
    Event Type
    Injury
    Date Received
    October 15, 2020
    Date of Event
    August 29, 2020
    Report Date
    November 2, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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 8141365. 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 EXTRAVASATION OCCURRED WHILE USING INTIMA-II Y 22GAX1.00IN PRN/EC SLM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO OUR DEPARTMENT ON AUGUST 25 DUE TO ADOLESCENT BLEEDING AND SEVERE HEMORRHAGIC ANEMIA. TRANSFUSION AND FLUID INFUSION WOULD BE PERFORMED AFTER HOSPITALIZATION. INTRAVENOUS INDWELLING NEEDLE 22 (BD: INTIMA-II) WAS PERFORMED IN THE RIGHT FOREARM, AND 0.9% SODIUM CHLORIDE + OMEPRAZOLE 60MG WILL BE INJECTED IN THE DAYS AHEAD. 100ML ALANYL GLUTAMINE + 250ML COMPOUND AMINO ACID; 250 ML 0.9% SODIUM CHLORIDE + SUCROSE IRON 5 ML, ETC., ON AUG. 27 17:00 INPUT AMMONIA ACYL GROUP C AFTER 100 ML, OF INFUSION FLUID LEAKAGE, PULLED OUT THE NEEDLE, THE SURROUNDING SKIN SLIGHTLY SWELLING, REDNESS, MINOR ACHES AND PAINS, AUGUST 29TH 9:30 TO SEE PATIENTS, FOUND RIGHT FOREARM SWELLING, PAIN, THE RIGHT UPPER LIMB B TO EXCEED CHECK, FOUND THAT THE CENTER OF THE RIGHT FOREARM VENOUS SHOWED LOW SOLID INSIDE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTRAVASATION OCCURRED WHILE USING INTIMA-II Y 22GAX1.00IN PRN/EC SLM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO OUR DEPARTMENT ON AUGUST 25 DUE TO ADOLESCENT BLEEDING AND SEVERE HEMORRHAGIC ANEMIA. TRANSFUSION AND FLUID INFUSION WOULD BE PERFORMED AFTER HOSPITALIZATION. INTRAVENOUS INDWELLING NEEDLE 22 (BD: INTIMA-II) WAS PERFORMED IN THE RIGHT FOREARM, AND 0.9% SODIUM CHLORIDE + OMEPRAZOLE 60MG WILL BE INJECTED IN THE DAYS AHEAD. 100ML ALANYL GLUTAMINE + 250ML COMPOUND AMINO ACID; 250 ML 0.9% SODIUM CHLORIDE + SUCROSE IRON 5 ML, ETC., ON AUG. 27 17:00 INPUT AMMONIA ACYL GROUP C AFTER 100 ML, OF INFUSION FLUID LEAKAGE, PULLED OUT THE NEEDLE, THE SURROUNDING SKIN SLIGHTLY SWELLING, REDNESS, MINOR ACHES AND PAINS, (B)(6) 9:30 TO SEE PATIENTS, FOUND RIGHT FOREARM SWELLING, PAIN, THE RIGHT UPPER LIMB B TO EXCEED CHECK, FOUND THAT THE CENTER OF THE RIGHT FOREARM VENOUS SHOWED LOW SOLID INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152375 INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other