BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTOSWAB - TEST KIT FOR SARS-COV-2

    MDR report key: 10964982 · Received December 8, 2020

    Report

    Report Number
    3007751444-2020-00001
    Event Type
    Malfunction
    Date Received
    December 8, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 19, 2020
    Manufacturer
    ROWEMED AG - MEDICAL FOR LIFE
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT WAS DELAYED DUE TO THE ENROLLMENT PROCESS.

    Description of Event or Problem · 1

    INITIAL USER MESSAGE: "IN THE CASE OF SAMPLING IN THE THROAT, THE TIP OF THE SWAB IS BROKEN OFF TWICE, SO THAT IT HAD TO BE REMOVED FROM THE THROAT. FOR THE SWAB WERE PLACED AN INTERNALLY RECALL IN THE ENTIRE UNIVERSITY HOSPITAL. THE AFFECTED BATCH WAS BLOCKED." NO FURTHER INFORMATION WAS GIVEN BY THE USER REGARDING THE HAZARD SITUATION AND THE EXACT FAILURE OF THE SWAB. THE DEFECTIVE PARTS WERE ALSO NOT PICKED UP AND COULD NOT BE INSPECTED. FROM THE INCOMPLETE DESCRIPTION, THE MANUFACTURER ASSUMES THAT THE SPATULA BROKE OFF AT THE PREDETERMINED BREAKING POINT WHEN EXCESSIVE PRESSURE WAS APPLIED DURING SAMPLING. THE PREDETERMINED BREAKING POINT IS NORMALLY USED FOR THE LATER SEPARATION OF THE SPATULA HEAD IN ORDER TO TRANSFER IT WITH THE COLLECTED SAMPLE MATERIAL INTO THE SAMPLE TUBE. THE SWAB HEAD WAS REMOVED FROM THE THROAT BY MEDICAL PERSONNEL. THERE WAS PROBABLY NO DETERIORATION OF THE HEALTH CONDITION. NO SERIOUS OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429145 CENTOSWAB - TEST KIT FOR SARS-COV-2 SWAB KXF ROWEMED AG - MEDICAL FOR LIFE A-10099 P0623-2005

    Patients

    Seq Age Sex Outcome Treatment
    1