BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY CATH PARA THORA N-VLV SFR

    MDR report key: 11143441 · Received January 8, 2021

    Report

    Report Number
    1625685-2021-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 24, 2020
    Report Date
    June 1, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403470820
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): NO SAMPLE WAS RETURNED FOR ANALYSIS. CONSEQUENTLY, THE INVESTIGATION WAS NOT ABLE TO FURTHER EVALUATE THE REPORTED FAILURE MODE THROUGH A COMPLAINT SAMPLE ANALYSIS. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. WITHOUT A SAMPLE, PHOTOGRAPH OR LOT INFORMATION THE INVESTIGATION WAS UNABLE TO CONFIRM THE FAILURE MODE NOR IDENTIFY A PROBABLE ROOT CAUSE. AS THE FAILURE MODE WAS UNABLE TO BE CONFIRMED NOR A ROOT CAUSE ABLE TO BE DETERMINED A CORRECTIVE AND/OR PREVENTIVE ACTION COULD NOT BE IDENTIFIED FOR THIS COMPLAINT. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED AND TRENDED FOR FUTURE OCCURRENCES. H3 OTHER TEXT: SEE NARRATIVE.

    Description of Event or Problem · 0

    MATERIAL NO: OTP5000SP; BATCH NO: UNKNOWN. IT WAS REPORTED THAT CATHETER BROKE OFF ITS BASE WHILE REMOVING CATHETER FROM PATIENT AS WE NORMALLY REMOVE WHEN COMPLETING PROCEDURE.  VERBATIM: ON TWO SEPARATE OCCASIONS CATHETER BROKE OFF ITS BASE WHILE REMOVING CATHETER FROM PATIENT AS WE NORMALLY REMOVE WHEN COMPLETING PROCEDURE. THE FIRST OCCASION I WITNESSES THIS HAPPEN WHILE THE RADIOLOGIST WAS PERFORMING THE PROCEDURE. THE SECOND INCIDENT THE CATHETER BROKE OFF WHILE I WAS COMPLETING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    PR (B)(4): INITIAL EMDR SUBMISSION. A DEVICE WAS TO BE RETURNED BUT NOT PROVIDED TO DATE. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    MATERIAL NO: OTP5000SP. BATCH NO: UNKNOWN.  IT WAS REPORTED THAT CATHETER BROKE OFF ITS BASE WHILE REMOVING CATHETER FROM PATIENT AS WE NORMALLY REMOVE WHEN COMPLETING PROCEDURE.  VERBATIM: ON TWO SEPARATE OCCASIONS CATHETER BROKE OFF ITS BASE WHILE REMOVING CATHETER FROM PATIENT AS WE NORMALLY REMOVE WHEN COMPLETING PROCEDURE. THE FIRST OCCASION I WITNESSES THIS HAPPEN WHILE THE RADIOLOGIST WAS PERFORMING THE PROCEDURE. THE SECOND INCIDENT THE CATHETER BROKE OFF WHILE I WAS COMPLETING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35853 TRAY CATH PARA THORA N-VLV SFR NEEDLE, CATHETER PXI CAREFUSION, INC OTP5000SP UNKNOWN 10885403470820

    Patients

    Seq Age Sex Outcome Treatment
    1