BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CATHETER

    MDR report key: 6955790 · Received October 17, 2017

    Report

    Report Number
    2026095-2017-00181
    Event Type
    Injury
    Date Received
    October 17, 2017
    Date of Event
    September 25, 2017
    Report Date
    November 29, 2017
    Manufacturer
    HALYARD - IRVINE
    Product Code
    BSO
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 19-DEC-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 16-OCT-2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LEFT KNEE SURGERY, CATHPLACE: LEFT GROIN, INFUSION START TIME: (B)(6) 2017 5:21 PM, INFUSION STOP TIME: (B)(6) 2017 5:21 PM. IT WAS REPORTED BY A PATIENT THAT SHE HAD SURGERY ON (B)(6) 2017 AND THE FIRST PUMP WAS PLACED THREE OR FOUR DAYS AFTER THE SURGERY. THE PATIENT PREVIOUSLY RETURNED TO THE HOSPITAL AND HAD A TOTAL OF 3 PUMPS ATTACHED USING THE ORIGINAL CATHETER. AT THE PATIENT'S PHYSICAL THERAPY APPOINTMENT, THE CATHETER AND THIRD PUMP WAS REMOVED AND ABOUT 5 INCHES FROM THE INSERTION SITE, THE PATIENT NOTED THE AREA TO BE RED, HOT, PAINFUL AND SWOLLEN. HOWEVER, THE ACTUAL INSERTION SITE WAS NOT PAINFUL. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735835 UNKNOWN CATHETER UNKNOWN CATHETER BSO HALYARD - IRVINE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other