BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 14240087 · Received April 28, 2022

    Report

    Report Number
    3014704491-2022-00161
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    March 5, 2022
    Report Date
    May 1, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    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

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

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1203256. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED 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 WHILE USING BD INTIMA-II 22GAX1.00IN PRN SLM NPVC LEAKAGE OCCURRED FROM THE CATHETER AND HUB JUNCTION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE PROCESS OF ARTERIAL PUNCTURE FOR THE PATIENT AT 11:00, ON (B)(6) 2022, THE NURSE FOUND CONTINUOUS BLEEDING AT THE JOINT OF THE INDWELLING NEEDLE, WHICH SHOULD BE CLOSED, IN THE EXTRACTION OF STEEL NEEDLE, IMMEDIATELY REMOVED THE NEEDLE AND RE-PUNCTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II 22GAX1.00IN PRN SLM NPVC LEAKAGE OCCURRED FROM THE CATHETER AND HUB JUNCTION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE PROCESS OF ARTERIAL PUNCTURE FOR THE PATIENT AT 11:00, ON (B)(6) 2022 , THE NURSE FOUND CONTINUOUS BLEEDING AT THE JOINT OF THE INDWELLING NEEDLE, WHICH SHOULD BE CLOSED, IN THE EXTRACTION OF STEEL NEEDLE, IMMEDIATELY REMOVED THE NEEDLE AND RE-PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115506 BD INTIMA-II 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1203256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown