BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVANTICS

    MDR report key: 8960014 · Received September 4, 2019

    Report

    Report Number
    1417592-2019-00154
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 20, 2019
    Manufacturer
    PDI/NICE-PAK PRODUCTS, INC.
    Product Code
    MCY
    UDI-DI
    10889942781843
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING FACILITY. PER REPORT, THE PATIENT REPORTEDLY HAS A HICKMAN CATHETER AND "FUZZ (FROM SWABSTICK) IS STILL STUCK TO HIS LINE, WE HAVE TRIED TO REMOVE WHAT WE CAN WITHOUT CAUSING HIM PAIN OR PULLING AT THE LINE, BUT THIS IS AN INFECTION RISK." NO ADDITIONAL INFORMATION WAS REPORTED. A SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THE MANUFACTURER OF THE SWAB STICK HAS BEEN NOTIFIED OF THIS INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT DURING SKIN PREP, STAFF NOTED "FUZZ PARTICLES" COMING OFF THE SWAB STICK (TAKEN FROM DRESSING CHANGE TRY). PER REPORT, THESE PARTICLES HAD IMBEDDED INTO THE PATIENT'S SKIN AND WERE NOT ABLE TO BE REMOVED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, NO FURTHER PATIENT, PRODUCT, PROCEDURAL, OR EVENT DETAILS ARE AVAILABLE. DUE TO THE REPORTED ISSUE AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. A SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. THE MANUFACTURER OF THE SWAB STICK HAS BEEN NOTIFIED OF THIS INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "FUZZ PARTICLES" WERE COMING OFF THE SWAB STICK (TAKEN FROM DRESSING CHANGE TRAY). PER REPORT, THE FUZZ PARTICLES HAD IMBEDDED DOWN INTO THE SKIN AND WERE NOT ABLE TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756995 PREVANTICS SWAB STICK IN DRESSING CHANGE TRAY MCY PDI/NICE-PAK PRODUCTS, INC. 18FBR284 10889942781843

    Patients

    Seq Age Sex Outcome Treatment
    1 Other