BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT IDENTIFICATION TAPE

    MDR report key: 8931838 · Received August 26, 2019

    Report

    Report Number
    MW5089320
    Event Type
    Malfunction
    Date Received
    August 26, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 21, 2019
    Manufacturer
    UNK
    Product Code
    LYV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I WAS DOING AN INFECTION PREVENTION CONSULTATION VISIT AT A HOSP AND REVIEWING THEIR STERILIZED INSTRUMENTS, I NOTICED THE USE OF WHAT IS CALLED "INSTRUMENT IDENTIFICATION TAPE." I LOOKED UP SEVERAL BRANDS AND CONTACTED THE MFR FOR THE USE OF INSTRUCTION AND WHICH STATE THE PRODUCT CAN BE LEFT ON THE INSTRUMENTS FOR MULTIPLE CYCLES OF DECONTAMINATION AND STERILIZATION. HOW IS THIS ALLOWED WHEN THE PRODUCT ITSELF IS AN ADHESIVE? HOW ARE PROPER STERILIZATION METHODS ABLE TO BE ADHERED TO WHEN TAPE IS ALLOWED TO BE LEFT ON THE INSTRUMENT? PER THE CDC GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE (2008) "CLEANING REMOVES THE BIOBURDEN AND REMOVES FOREIGN MATERIAL (I. E., ORGANIC RESIDUE AND INORGANIC SALTS) THAT INTERFERES WITH THE STERILIZATION PROCESS BY ACTING AS A BARRIER TO THE STERILIZATION AGENT." IF TAPE, AN ADHESIVE, IS LEFT ON AN ITEM, HOW DOES IT NOT ALLOW ORGANIC MATTER TO STICK TO THE INSTRUMENT? FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726810 INSTRUMENT IDENTIFICATION TAPE LABEL OR TAG, STERILE LYV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1