BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS KIT 8FR X 16CM- PIG1280K

    MDR report key: 14684634 · Received June 14, 2022

    Report

    Report Number
    9680904-2022-00026
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    June 2, 2022
    Report Date
    July 29, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    PXI
    UDI-DI
    10885403076107
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: THREE PHOTO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTOS, FOR LOT NUMBER 00001446110 IT WAS OBSERVED THAT THE BOTTOM HALF OF THE INFORMATION, WHICH INCLUDE THE EXPIRATION DATE IS NOT INCLUDED IN THE LABEL; 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 0001446110 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. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND ADDITIONAL TRAINING WAS PROVIDED. 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.

    Description of Event or Problem · 0

    NO EXPIRY DATE ON INNER. IT WAS REPORTED THAT ONLY THE OUTER UNIT DISPLAYED AN EXPIRY DATE. AFTER OPENING THE OUTER PACKAGE, THE INNER PACKAGE ONLY DISPLAYED A LOT NUMBER AND NOT THE EXPIRY DATE. CUSTOMER EXPRESSED DISSATISFACTION WITH THIS AS SHE BELIEVES THE EXPIRY DATE SHOULD BE PRINTED ON BOTH THE INNER AND OUTER PACKAGING.

    Description of Event or Problem · 0

    NO EXPIRY DATE ON INNER. IT WAS REPORTED THAT ONLY THE OUTER UNIT DISPLAYED AN EXPIRY DATE. AFTER OPENING THE OUTER PACKAGE, THE INNER PACKAGE ONLY DISPLAYED A LOT NUMBER AND NOT THE EXPIRY DATE. CUSTOMER EXPRESSED DISSATISFACTION WITH THIS AS SHE BELIEVES THE EXPIRY DATE SHOULD BE PRINTED ON BOTH THE INNER AND OUTER PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366123 SAFE-T-CENTESIS KIT 8FR X 16CM- PIG1280K THORACENTESIS TRAY PXI CAREFUSION, INC PIG1280K 0001446110 10885403076107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other