BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18G X 1.16IN (1.3 X 30 MM) W/ Y INTIMA II

    MDR report key: 9082882 · Received September 18, 2019

    Report

    Report Number
    3006948883-2019-00775
    Event Type
    Malfunction
    Date Received
    September 18, 2019
    Date of Event
    July 1, 2019
    Report Date
    October 9, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MFR. REPORT # 3006948883-2019-00775 IS VOID. THE COMPLAINT HAS BEEN CAPTURED UNDER MFR. REPORT # 3006948883-2019-00584.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE 18G X 1.16IN (1.3 X 30 MM) W/ Y INTIMA II HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE USED THE INTRAVENOUS INDWELLING NEEDLE TO INFUSE THE PATIENT: AFTER THE INJECTION AND PULLING THE HARD NEEDLE, THERE IS BLOOD LEAKAGE IN THE PLACE WHERE THE NEEDLE IS PULLED. NEED TO REPLACE THE INDWELLING NEEDLE AND NEED TO RE-PENETRATE. THERE IS A POSSIBILITY OF INCREASING THE CHANCE OF INFECTION.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE 18G X 1.16IN (1.3 X 30 MM) W/ Y INTIMA II HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE USED THE INTRAVENOUS INDWELLING NEEDLE TO INFUSE THE PATIENT: AFTER THE INJECTION AND PULLING THE HARD NEEDLE, THERE IS BLOOD LEAKAGE IN THE PLACE WHERE THE NEEDLE IS PULLED. NEED TO REPLACE THE INDWELLING NEEDLE AND NEED TO RE-PENETRATE. THERE IS A POSSIBILITY OF INCREASING THE CHANCE OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879023 18G X 1.16IN (1.3 X 30 MM) W/ Y INTIMA II INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7047028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other