BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS KIT 6FR X 16CM- PIG1260K

    MDR report key: 12053529 · Received June 23, 2021

    Report

    Report Number
    9680904-2021-00067
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 14, 2021
    Report Date
    August 16, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403076114
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: THREE PHOTOS AND ONE SAMPLE OF LOT 0001373678 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. DURING VISUAL INSPECTION IT WAS OBSERVED THAT THE POUCH IS NOT SEALED CORRECTLY. THE SEAL IN THE POUCH APPEARS TO BE INCOMPLETE; THEREFORE, THE REPORTED FAILURE COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR REPORTED LOT 0001373678 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT MANUFACTURING, INCLUDING VERIFICATION THAT THE PACKAGE SEAL IS COMPLETE AND FREE FROM DEFECTS, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. A REVIEW OF MACHINE RECORDS VERIFIED THAT ALL MACHINE PARAMETERS WERE WITHIN REQUIRED LIMITS, THERE WAS NO EVIDENCE THAT ANY CORRECTIVE MAINTENANCE WAS PERFORMED ON THE SEALING MACHINES. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCES. H3 OTHER TEXT : SEE MANUFACTURER HERE.

    Description of Event or Problem · 0

    ITEM RECEIVED IN LAST ORDER AND WAS NOT SEALED CORRECTLY, THEREFORE PRODUCT WAS NOT STERILE AND COULD NOT BE USED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ITEM RECEIVED IN LAST ORDER AND WAS NOT SEALED CORRECTLY, THEREFORE PRODUCT WAS NOT STERILE AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947981 SAFE-T-CENTESIS KIT 6FR X 16CM- PIG1260K THORACENTESIS TRAY PXI CAREFUSION, INC PIG1260K 0001373678 10885403076114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other