BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 11159205 · Received January 13, 2021

    Report

    Report Number
    3006948883-2021-00065
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    November 30, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: UNABLE TO VIEW THE BATCH RECORD BECAUSE THE BATCH NUMBER OF THE COMPLAINT (B)(4) COULD NOT BE FOUND. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, PATIENTS WITH SUSPECTED AORTIC DISSECTION IN THE EMERGENCY DEPARTMENT UNDERWENT ENHANCED CT EXAMINATION. THE HEPARIN CAP BROKEN DURING THE INJECTION OF THE CONTRAST AGENT, WHICH CAUSED THE CONTRAST AGENT INJECTION, THE HIGH-PRESSURE PUMP WAS STOPPED, THE HEPARIN CAP WAS REPLACED AND THE CONTRAST AGENT WAS REDRAWN AND THE CONTRAST AGENT WAS INJECTED TO COMPLETE THE ENHANCED CT SCANNING, THE PATIENT DID NOT CAUSE HARM, BUT THE MEDICINE WAS WASTED AND THE SCANNING TIME FOR THE PATIENT WAS PROLONGED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 0231157. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, PATIENTS WITH SUSPECTED AORTIC DISSECTION IN THE EMERGENCY DEPARTMENT UNDERWENT ENHANCED CT EXAMINATION. THE HEPARIN CAP BROKEN DURING THE INJECTION OF THE CONTRAST AGENT, WHICH CAUSED THE CONTRAST AGENT INJECTION, THE HIGH-PRESSURE PUMP WAS STOPPED, THE HEPARIN CAP WAS REPLACED AND THE CONTRAST AGENT WAS REDRAWN AND THE CONTRAST AGENT WAS INJECTED TO COMPLETE THE ENHANCED CT SCANNING, THE PATIENT DID NOT CAUSE HARM, BUT THE MEDICINE WAS WASTED AND THE SCANNING TIME FOR THE PATIENT WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62892 INTIMA-II Y 20GAX1.16IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1