BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T PLUS THORACENTESIS/PARACENTESIS

    MDR report key: 19771467 · Received July 18, 2024

    Report

    Report Number
    1625685-2024-00081
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 27, 2024
    Report Date
    September 11, 2024
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403108433
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. A PHOTO OF THE DEFECT COULD ASSIST OUR QUALITY TEAM IN THEIR INVESTIGATION. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS OF THE AFFECTED DEVICE. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0401. PATIENT PROBLEM CODE: F26.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. THEY HAD TO OPEN ANOTHER TRAY TO COMPLETE THE PROCEDURE. PRODUCT NUMBER - TPT1000SP. LOT NUMBER - 00018559052. DESCRIBE PATIENT / HCP / USER IMPACT - OPENED ANOTHER TRAY TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE INTRODUCER NEEDLE BROKE DURING THE PROCEDURE. THEY HAD TO OPEN ANOTHER TRAY TO COMPLETE THE PROCEDURE. DESCRIBE PATIENT / HCP / USER IMPACT - OPENED ANOTHER TRAY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552396 SAFE-T PLUS THORACENTESIS/PARACENTESIS THORACENTESIS TRAY PXI CAREFUSION, INC UNKNOWN 10885403108433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other