BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHUNT PAK, 11.5FR DOUBLE-VALVE

    MDR report key: 14348417 · Received May 10, 2022

    Report

    Report Number
    1625685-2022-00049
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 26, 2022
    Report Date
    July 7, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    KPM
    UDI-DI
    50885403421370
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    PR 5064896 FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO AND TWO SEALED PRODUCT TRAYS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, OF THE FIRST TRAY FOREIGN MATTER WAS OBSERVED. THE SECOND TRY WERE EXAMINED TWO 16FR SIZE INTRODUCER WERE OBSERVED; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001453124 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 QUALITY TEAM'S INVESTIGATION, PROBABLE ROOT CAUSES WERE DETERMINED AS MANUFACTURING RELATED. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND ADDITIONAL TRAINING WAS PROVIDED. 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 THE CUSTOMER THAT "THERE IS A LONG HAIR IN THE TRAY" AND " THERE ARE TWO PIECES OF 16FR. INTRODUCERS IN A KIT. AND 12 FR. IS NOT INCLUDED". VERBATIM: THERE IS A LONG HAIR IN THE TRAY. CATALOG NO. 42-2090, LOT 0001453124, QUANTITY 1. WE FOUND OUT DURING INCOMING INSPECTION AT (B)(6). SO THEY ARE NOT USED ON THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT "THERE IS A LONG HAIR IN THE TRAY" AND " THERE ARE TWO PIECES OF 16FR. INTRODUCERS IN A KIT. AND 12 FR. IS NOT INCLUDED". VERBATIM: THERE IS A LONG HAIR IN THE TRAY. (SEE ATTACHED PHOTO) CATALOG NO. 42-2090 LOT 0001453124 QUANTITY 1. WE FOUND OUT DURING INCOMING INSPECTION AT MIHAMA. SO THEY ARE NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171404 SHUNT PAK, 11.5FR DOUBLE-VALVE NA KPM CAREFUSION, INC 0001453124 50885403421370

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other