BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    HEALTH CARE TECHNOLOGY

    MDR report key: 14047452 · Received April 7, 2022

    Report

    Report Number
    1000111025-2022-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    February 20, 2022
    Report Date
    March 12, 2022
    Manufacturer
    STRADIS HEALTHCARE
    Product Code
    OFF
    UDI-DI
    M752HCT541BP20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT INDICATED NORMALLY ALL OF THE SUPPLIES ARE ON THE WHITE PART OF THE STERILE FIELD. 3/5 KITS YESTERDAY HAD SUPPLIES ON THE BLUE PART WHICH MEANT YOU DID NOT HAVE A STERILE FIELD. HOWEVER, DUE TO THE EO GAS STERILIZATION PROCESS, BOTH SIDES OF THE CSR WRAP ARE STERILIZED. UPON RECEIPT OF THE COMPLAINT, THE IMPACT TO THE PATIENT WAS ASSESSED AND DETERMINED TO BE A DELAY IN A ROUTINE PROCEDURE NOT A LIFE-SAVING EVENT. ADDITIONALLY, THE ISSUE WAS DETERMINED NOT TO ADVERSELY AFFECT THE STERILE BARRIER NOR THE STERILITY OF THE CONTENTS. THEREFORE WHILE THIS ISSUE MAY HAVE RESULTED IN A TREATMENT DELAY, IT DID NOT INCREASE THE PATIENT EXPOSURE TO NON-STERILE DEVICES. AS A RESULT OF THE REVIEW THIS WAS INVESTIGATED AS A CUSTOMER COMPLAINT. IT WAS DETERMINED NOT TO QUALIFY AS A MEDICAL DEVICE REPORTABLE EVENT. NOR DID THIS ASSESSMENT INDICATE THAT ADDITIONAL FIELD ACTIONS WERE REQUIRED. DURING THE INVESTIGATION, A REVIEW OF THE WORK INSTRUCTIONS WITH ASSEMBLER INDICATED THE INSTRUCTIONS RESULTED IN SOME CONFUSION INDICATING THE INSTRUCTIONS WERE AT THE ROOT AND MAY HAVE CONTRIBUTED TO QUALITY INSPECTORS FAILING TO DETECT THE ERRORS. THE WORK INSTRUCTIONS HAVE SINCE BEEN REVISED.

    Description of Event or Problem · 0

    CUSTOMER INDICATED THAT THE CENTRAL LINE KIT ARRIVED, WHERE THE SUPPLIES WERE PLACED ON THE BLUE"PART, WHICH MEANT THAT THE ITEMS WERE NOT ON A STERILE FIELD. HOWEVER, IT SHOULD BE NOTED THAT THE BOTH SIDES OF THE WRAP GO THROUGH THE STERILIZATION PROCESS (STRADIS STERILIZATION LOAD# M20104 AT (B)(6)) SO IN FACT THERE IS A STERILE FIELD STILL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703960 HEALTH CARE TECHNOLOGY CENTRAL LINE KIT OFF STRADIS HEALTHCARE HCT541BP-2 220040148 M752HCT541BP20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown