BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX EPIDURAL CATHETER

    MDR report key: 19182297 · Received April 25, 2024

    Report

    Report Number
    3012307300-2024-03016
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    March 25, 2024
    Report Date
    June 18, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSO
    UDI-DI
    15019517073935
    PMA / PMN Number
    K062005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9. DATE RETURNED TO MFG: 09-MAY-2024. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: ONE USED DECONTAMINATED SAMPLE OF 007/374/418, WHICH IS PART OF THE 24-1301-22 NRFIT CONNECTOR, AND ONE SAMPLE OF LOCKIT PLUS - WHICH ISN´T PART OF CLAIMED 24-1301-22 - WERE RECEIVED WITHOUT THEIR ORIGINAL PACKAGING FOR EVALUATION. RECEIVED SAMPLES WERE VISUALLY INSPECTED AND THERE WAS NO PROBLEM FOUND. ACCORDING TO THE EVENT DESCRIPTION THE CLAIMED ISSUE WAS OBSERVED AT THE CONNECTOR, WHICH WASN´T PART OF THE RECEIVED SAMPLES. THUS, WE WERE UNABLE TO FURTHER INVESTIGATE THE ISSUE AND THE ROOT CAUSE REMAINS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    H3 OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTOR ON THE DEVICE COMPLETELY SNAPPED OFF. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855288 PORTEX EPIDURAL CATHETER CATHETER, CONDUCTION, ANESTHETIC BSO SMITHS MEDICAL ASD, INC. 4138095 15019517073935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention