BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEO-SERT UVC TRAY W/O C

    MDR report key: 11897645 · Received May 27, 2021

    Report

    Report Number
    3009211636-2021-00749
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    May 19, 2021
    Report Date
    August 9, 2021
    Product Code
    PXJ
    UDI-DI
    10884527005079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT REPORTED IS A UVC INSERTION TRAY WHICH PROVIDES THE COMPONENTS NEEDED FOR CONDUCTING A CATHETER INSERTION PROCEDURE. ONE OF THE COMPONENTS INCLUDED IN THIS KIT IS A SAFETY SCALPEL WHICH IS PROVIDED BY AN EXTERNAL SUPPLIER. THE SCALPEL HAS 3 DIFFERENT POSITIONS: OPEN, CLOSE AND LOCKED. ONCE LOCKED, AND FOR SAFETY REASONS AS THE NAME INDICATES, IT CANNOT BE RE-OPENED. THIS LOCKING FEATURE WAS IMPLEMENTED TO MEET OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA) REQUIREMENTS TO PREVENT SHARPS INJURIES. TO INITIALLY OPEN THE SCALPEL, FORCE NEEDS TO BE APPLIED TOWARDS THE OPEN SIGN. IF THE SECURITY LID IS MOVED TOWARDS THE BLADE (UPWARDS), THE LID WILL LOCK, AND THE SCALPEL CANNOT BE USED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. ALL QUALITY ASSURANCE TESTING PERFORMED DURING MANUFACTURING WAS ACCEPTABLE. THE QUALITY ASSURANCE REVIEW OF THE VISUAL, PHYSICAL, AND DIMENSIONAL EVALUATION RESULTS INDICATED THAT THE PRODUCT MET SPECIFICATION REQUIREMENTS. IN ADDITION, ALL DHR ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE ACTUAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES, OR VIDEOS WERE RECEIVED. CONSEQUENTLY, IT WAS NOT POSSIBLE TO EVALUATE THE DEVICE AS PART OF A COMPREHENSIVE FAILURE INVESTIGATION AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. PRELIMINARY EVALUATION SHOWS THAT THE REPORTED ISSUE IS POTENTIALLY RELATED TO INADVERTENTLY LOCKING THE SCALPEL DURING IMPROPER HANDLING OF THE PRODUCT. ADDITIONALLY, IT WAS FOUND THAT THE REPORTED UVC KIT DOES NOT INCLUDE INSTRUCTIONS FOR USE (IFU) FOR THE SCALPEL. BASED ON A MEDICAL SAFETY ASSESSMENT, NOT INCLUDING THE IFU INFORMATION FOR THE SAFETY SCALPEL PREVENTS CLINICIANS FROM BEING MADE AWARE OF THE PERMANENT LOCKING FEATURE OF THIS SAFETY SCALPEL WHICH CAN CREATE A DELAY TO TREATMENT/THERAPY AND MAY CONTRIBUTE TO PATIENT/USER HARM. AS PART OF CONTINUOUS IMPROVEMENTS, A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED. AN IFU FOR THE SAFETY SCALPEL WILL BE CREATED AND INCORPORATED INTO THE UVC KIT TRAY PART NUMBER 43201. THE CAPA WILL ALSO DETERMINE IF ANY ADDITIONAL ACTIONS ARE NEEDED TO PREVENT THE REOCCURRENCE OF THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    SECTION D2 PRODUCT CODE UPDATED FROM FOS CATHETER, UMBILICAL ARTERY TO PXJ UMBILICAL CATHETER INSERTION TRAY.;

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION.  IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.  AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: THE #11 SAFETY SCALPEL IN THE KIT WILL NOT DISENGAGE THE SAFETY DEVICE FOR THE SCALPEL TO BE USED. ANOTHER TRAY WAS USED AND THE SAFETY DEVICE DISENGAGED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793841 SAFETY NEO-SERT UVC TRAY W/O C UMBILICAL CATHETER INSERTION TRAY PXJ 43201 2102100068 10884527005079
    793842 SAFETY NEO-SERT UVC TRAY W/O C UMBILICAL CATHETER INSERTION TRAY PXJ 43201 2102100068 10884527005079

    Patients

    Seq Age Sex Outcome Treatment
    1