BEUDAMED
    FDA Adverse Event Death Summary report: N

    SAFETY NEO-SERT UVC TRAY W/O C

    MDR report key: 10997272 · Received December 13, 2020

    Report

    Report Number
    3009211636-2020-00727
    Event Type
    Death
    Date Received
    December 13, 2020
    Report Date
    August 20, 2021
    Manufacturer
    COVIDIEN
    Product Code
    PXJ
    UDI-DI
    10884527005079
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE A LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. ONE REPRESENTATIVE SAMPLE WITH UNKNOWN LOT NUMBER WAS RECEIVED FOR THE ANALYSIS. UPON VISUAL INSPECTION OF THE SAMPLE (SCALPEL), DRAG MARKS IN THE BODY OF THE COMPONENT WAS OBSERVED, AND THAT COULD INDICATE A USE OF SOME TOOL DURING OPERATION. THE REPORTED ISSUE IS CONFIRMED, AS THIS COMPONENT WAS RECEIVED IN A CLOSED POSITION. TO IDENTIFY THE ROOT CAUSE OR THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE, THE LOCAL PROCEDURES USED DURING PACKAGING OF THIS PRODUCT WAS REVIEWED. THE MATERIAL IS RECEIVED IN TRAYS FROM SUPPLIER (THE TRAY IS DESIGNED TO AVOID BLOCKAGE). THE TRAY DOES NOT ALLOW THE MOVEMENT OF THE SCALPEL TOWARDS THE BLADE. THE SCALPELS WILL BE RECEIVED IN AN OPEN (UNLOCK) POSITION. AFTER RECEIVING THE COMPONENT, INCOMING INSPECTION PERFORMS A SAMPLING AND INSPECTS FOR DAMAGE IN THE COMPONENT INCLUDED THAT IS NOT BLOCKED AND LATER, KITING ROOM SENDS THE SCALPEL TO THE MANUFACTURING FLOOR IN THE ORIGINAL TRAY. ACCORDING TO THE PROCEDURE: THE SCALPEL MUST ALWAYS BE KEPT IN ITS TRAY TO PREVENT THEM FROM LOCKING BEFORE BEING INSERTED INTO THE FINAL PACKING TRAY. TAKE ONE SCALPEL AT A TIME. REMOVE THE SCALPEL FROM THE ORANGE AREA TRAY. DO NOT MOVE THE PROTECTIVE COVER AS IT CAN LOCK IT. VISUALLY CHECK THAT IT IS IN ITS OPEN POSITION, IF ANY SCALPEL IS CLOSED, IT MUST BE DISCARDED. IT IS IMPORTANT TO MENTION THAT THE SCALPEL HAS A PLASTIC SAFETY LID WITH THE PURPOSE OF ASSURING THAT THE USER DOES NOT GET CUT WHEN MANIPULATING THE SCALPEL PRIOR THE USE. THIS PLASTIC COVER ALSO SERVES TO BLOCK THE SCALPEL AFTER IT¿S USED TO AVOID ADDITIONAL MANIPULATION AND SAFETY DISPOSAL. TO OPEN THE SCALPEL, FORCE NEEDS TO BE APPLIED TOWARDS THE OPEN SIGN. IF THE SECURITY LID IS MOVED TOWARDS THE BLADE (UPWARDS) THE LID GETS BLOCKED AND THE SCALPEL CANNOT BE USED. DUE TO IT TAKES SOME FORCE TO OPEN IT AND BASED ON THE DRAG MARKS FOUND IN THE REPRESENTATIVE SAMPLE, IT COULD BE DUE TO USING A TOOL OR INSTRUMENT TO OPEN THE SCALPEL, AS APPLYING MUCH FORCE WOULD CAUSE IT TO LOCK. BASED ON THE CONTROLS ESTABLISHED ABOVE, THE REPORTED ISSUE COULD NOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS. THE MOST PROBABLE ROOT CAUSE COULD BE BECAUSE OF CUSTOMER MISUSE, DUE TO AN INCORRECT HANDLING OF THE SECURITY LID THAT COULD BE CAUSING BY SOME INSTRUMENT FOR EASE MOVING THE LOCK SWITCH SYSTEM. NO ACTION IS DEEMED NECESSARY AT THIS TIME. IT MUST BE NOTED THAT IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING ARE PERFORMED IN THE PLANT) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IN ORDER TO EXPAND ON THE INVESTIGATION A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) AND SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAVE BEEN OPENED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE WAS DISCARDED. A REPRESENTATIVE 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN EMERGENCY SITUATION THE SCALPEL IN THE UVC SET APPEARED LOCKED AND WAS UNABLE TO BE OPENED BY THE PROVIDERS DURING A NEONATAL CODE SITUATION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2020 STATED THAT THERE WAS LESS THAN A MINUTE OF A DELAY IN INSERTING THE UVC LINE DURING AN ADVANCED RESUSCITATION IN A C-SECTION. THE NEWBORN EXPIRED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2020 STATED THAT THEY COULD NOT PULL THE SCALPELS SAFETY SHEATH DOWN, STATING THAT IT WAS LOCKED IN". THE CUSTOMER STATED THAT SINCE THE INCIDENT OCCURRED IN AN EMERGENCY SITUATION, SHE DOES NOT KNOW IF THE SCALPEL WAS ALREADY IN THE LOCKED POSITION WHEN REMOVED FROM THE UVC KIT. SHE STATED THAT THEY USED A DIFFERENT SCALPEL THAT THEY GOT FROM THE OR TABLE AS A REPLACEMENT TO PLACE THE LINE. THE CUSTOMER WOULD NOT ANSWER IF THEY BELIEVED THAT THE ISSUE WITH THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENTS DEATH. THE CUSTOMER STATED THAT ALL SHE WILL SAY IS THAT THE BABY WAS IN FETAL DISTRESS WHICH IS WHY THEY NEEDED TO PLACE THE UVC LINE. NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462646 SAFETY NEO-SERT UVC TRAY W/O C UMBILICAL CATHETER INSERTION TRAY PXJ COVIDIEN 43201 10884527005079

    Patients

    Seq Age Sex Outcome Treatment
    1 Death