BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC NON-STERILE DISPOSABLE SAFETY SCALPEL

    MDR report key: 11808927 · Received May 11, 2021

    Report

    Report Number
    8022003-2021-00001
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED NOTIFICATION OF THIS INCIDENT ON APRIL 15, 2021. PER THE CUSTOMER, THE SAFETY SCALPEL, AS PART OF AN UMBILICAL VESSEL CATHETER (UVC) TRAY, WOULD NOT OPEN AS IT WAS IN THE LOCKED POSITION, WHICH DELAYED UVC PLACEMENT. THE CUSTOMER COULD NOT CONFIRM IF THE SCALPEL WAS RECEIVED IN THE LOCKED POSITION OR IF LOCKING OCCURRED IN THE EMERGENCY ROOM. THIS INCIDENT WAS ALSO REPORTED BY THE UVC KIT MANUFACTURER (3009211636-2020-00726). THE SAFETY SCALPEL ASSOCIATED WITH THE INCIDENT IS SOLD IN BULK TO THE KIT MANUFACTURER FOR FURTHER PACKAGING INTO PROCEDURE KITS. QUALITY CONTROL CHECKS ARE UTILIZED BY THE SAFETY SCALPEL MANUFACTURER TO ENSURE SCALPELS ARE NOT PROVIDED IN A LOCKED POSITION. THE INCIDENT WAS LIKELY DUE TO USER ERROR DUE TO MISUNDERSTANDING OF HOW THE SAFETY SCALPEL OPENS, CLOSES AND LOCKS. ALTERNATIVE SCALPEL BRANDS MAY HAVE SHEATHS THAT ARE FULLY REMOVED TO EXPOSE THE BLADE. THE MANUFACTURER SAFETY SCALPELS RETRACT TO EXPOSE THE BLADE, MAY BE CLOSED FOR SAFE PASSING AND CAN BE LOCKED FOR SAFE DISPOSAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT IN AN EMERGENCY SITUATION THE SCALPEL IN THE UVC SET APPEARED LOCKED AND WAS UNABLE TO BE OPENED BY THE PROVIDER DURING A NEONATAL CODE SITUATION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THERE WAS A DELAY IN TREATMENT BUT WAS UNSURE HOW LONG THE DELAY WAS. THE CUSTOMER STATED IT WAS A CRITICAL SITUATION IN THE DELIVERY ROOM AND THAT THE NEWBORN NEEDED ADVANCED RESUSCITATION QUICKLY. THE UVC LINE NEEDED TO BE PLACED BUT THE SCALPEL COULD NOT BE OPENED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THEY COULD NOT PULL THE SCALPEL SAFETY SHEATH DOWN, STATING THAT IT WAS LOCKED IN. THE CUSTOMER STATED THAT SINCE THE INCIDENT OCCURRED IN AN EMERGENCY SITUATION, THEY DO NOT KNOW IF THE SCALPEL WAS ALREADY IN THE LOCKED POSITION WHEN REMOVED FROM THE UVC KIT. THEY STATED THAT THEY WERE FINALLY ABLE TO OPEN THE SCALPEL AND PLACE THE LINE INTO THE PATIENT. THE NEWBORN EXPIRED. THE CUSTOMER WOULD NOT ANSWER IF THEY BELIEVED THAT THE ISSUE WITH THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706317 SOUTHMEDIC NON-STERILE DISPOSABLE SAFETY SCALPEL SCALPEL GES SOUTHMEDIC INC. 73-1811 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other