BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 13283193 · Received January 18, 2022

    Report

    Report Number
    3014704491-2021-00455
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    October 22, 2021
    Report Date
    February 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0238626, MEDICAL DEVICE EXPIRATION DATE: 2023-09-23, DEVICE MANUFACTURE DATE: 2020-08-25; MEDICAL DEVICE LOT #: 0357724, MEDICAL DEVICE EXPIRATION DATE: 2023-09-23, DEVICE MANUFACTURE DATE: 2020-08-25; MEDICAL DEVICE LOT #: 0019787, MEDICAL DEVICE EXPIRATION DATE: 2023-09-23, DEVICE MANUFACTURE DATE: 2020-08-25; MEDICAL DEVICE LOT #: 1111465, MEDICAL DEVICE EXPIRATION DATE: 2023-09-23, DEVICE MANUFACTURE DATE: 2020-08-25.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/27/2021. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0357724 . 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 PHOTOGRAPH WAS SUBMITTED DISPLAYING THE IRRITATION EXPERIENCED BY THE PATIENTS, BUT DID NOT DISPLAY THE AFFECTED DEVICE. THE PHYSICAL SAMPLES ALSO WERE SUBMITTED TO AID IN OUR INVESTIGATION INTO THIS ISSUE. FUNCTIONAL TESTING OF THE RETURNED UNITS WAS NOT ABLE TO DETECT ANY BURRS OR OTHER ABNORMALITIES THAT COULD HAVE RESULTED IN THE OBSERVE ADVERSE EVENT. ADDITIONALLY THIS LOT WAS TREATED AND RECEIVED A CERTIFICATE OF CONFORMANCE FOR STERILITY. BASED ON THESE OBSERVATIONS OUR ENGINEERS WERE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING 16 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS MEDICAL INTERVENTION WAS PERFORMED DUE TO PHLEBITIS. AN INFUSION OF OXYTOCIN AND MAGNESIUM SULFATE WAS MAINTAINED BY MIRCROPUMP. THE NEEDLE WAS REMOVED AND THROMBOSIS WAS FOUND ACCORDING TO A B-ULTRASOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INFUSION OF OXYTOCIN AND MAGNESIUM SULFATE WAS MAINTAINED BY MICROPUMP. THE NEEDLE WAS REMOVED IMMEDIATELY AFTER PHLEBITIS WAS FOUND LATER, AND THROMBOSIS WAS FOUND ACCORDING TO B-ULTRASOUND."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING 16 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS MEDICAL INTERVENTION WAS PERFORMED DUE TO PHLEBITIS. AN INFUSION OF OXYTOCIN AND MAGNESIUM SULFATE WAS MAINTAINED BY MIRCROPUMP. THE NEEDLE WAS REMOVED AND THROMBOSIS WAS FOUND ACCORDING TO A B-ULTRASOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE INFUSION OF OXYTOCIN AND MAGNESIUM SULFATE WAS MAINTAINED BY MICROPUMP. THE NEEDLE WAS REMOVED IMMEDIATELY AFTER PHLEBITIS WAS FOUND LATER, AND THROMBOSIS WAS FOUND ACCORDING TO B-ULTRASOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217016 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention