BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORA/PARA TRAY, 5FR, NON-VALVED

    MDR report key: 14373353 · Received May 12, 2022

    Report

    Report Number
    1625685-2022-00051
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 18, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403284748
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. DURING VISUAL INSPECTION, SEPARATED CATHETER TUBE AND A HUB WAS OBSERVED. THE SPECIFICATION, FOR THE TUBE AND HUB TO SEPARATE AT ABOUT 3 POUNDS OF FORCE, INDICATES THE ITEM ALLOWED THE SEPARATION AND WAS WORKING AS INTENDED. THE SEPARATION WAS CONFIRMED. THIS IS NOT CONSIDERED AS A FAILURE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001458459 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT: SEE MANUFACTURE NARRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT PIECE BROKE APART. EMAIL VERBATIM: HERE ARE THE PICTURES OF THE PRODUCT INFORMATION AND THE PIECE THAT BROKE APART. WAS THE CATHETER BROKE DURING THE PROCEDURE OR BEFORE THE PROCEDURE? THE TUBE BROKE AWAY FROM THE HUB WHEN IT WAS BEING REMOVED FROM THE PATIENT¿S CHEST. NO DEFECT WAS NOTICED PRIOR TO USE. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? WHAT WAS THE IMPACT TO THE PATIENT? HOW WAS THE ISSUE RESOLVED? (B)(6) 2022: THE PATIENT HAD A SMALL PNEUMOTHORAX. IT DID RESOLVE AND WE DID NOT HAVE TO PUT A CHEST TUBE IN.

    Description of Event or Problem · 0

    MATERIAL # OTP5000. BATCH # 0001458459. IT WAS REPORTED BY CUSTOMER THAT PIECE BROKE APART. EMAIL VERBATIM: HERE ARE THE PICTURES OF THE PRODUCT INFORMATION AND THE PIECE THAT BROKE APART. WAS THE CATHETER BROKE DURING THE PROCEDURE OR BEFORE THE PROCEDURE? THE TUBE BROKE AWAY FROM THE HUB WHEN IT WAS BEING REMOVED FROM THE PATIENT¿S CHEST. NO DEFECT WAS NOTICED PRIOR TO USE. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? WHAT WAS THE IMPACT TO THE PATIENT? HOW WAS THE ISSUE RESOLVED? ON 06MAY2022: THE PATIENT HAD A SMALL PNEUMOTHORAX. IT DID RESOLVE AND WE DID NOT HAVE TO PUT A CHEST TUBE IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084026 THORA/PARA TRAY, 5FR, NON-VALVED THORACENTESIS TRAY PXI CAREFUSION, INC OTP5000 0001458459 10885403284748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other