BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESHEATH® ULTRA LITE

    MDR report key: 20359252 · Received October 3, 2024

    Report

    Report Number
    1035166-2024-00102
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    August 21, 2024
    Report Date
    October 4, 2024
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    25051684026281
    PMA / PMN Number
    K073100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS PROVIDED FOR ANALYSIS. THE CUSTOMER STATED THE PEELAWAY SHEATH DOES NOT SNAP APART. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. NO PRODUCT WAS RETURNED TO OSCOR INC. FOR EVALUATION; HOWEVER, A COMPLAINT NOTIFICATION WAS PROVIDED. WITHOUT THE RETURN OF THE ACTUAL DEVICE IN QUESTION FOR EVALUATION, OSCOR INC. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS INCIDENT. AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. THE COMPLAINT IS NON-VERIFIABLE AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY HAVE NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PROCEDURE WAS A PORT PLACEMENT. THE EVENT OCCURRED DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

    Description of Event or Problem · 0

    AN END USER REPORTED AN ISSUE WITH TWO CT W/8FR DETACHED POLY CATH W/VI SMARTPORTS. IT WAS REPORTED THAT THE PEELAWAY SHEATH DOES NOT SNAP APART, REQUIRING THE END USER TO CUT THE PLASTIC CENTER PIECE IN ORDER TO USE THE SHEATH. THERE WAS NO REPORT OF PATIENT HARM OR ADVERSE EVENT BY THE END USER. THE CUSTOMER REPORTED TWO OCCURRENCES OF THIS ISSUE FOR THE SPECIFIED LOT NUMBER. ADDITIONAL COMPLAINT REPORTED: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869087 SAFESHEATH® ULTRA LITE INTRODUCER, CATHETER DYB OSCOR INC. VI85 DP-21286 25051684026281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown