BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERMARK PERIPHERALLY INSERTED CENTRAL CATHETER/EXACT CODE

    MDR report key: 40583 · Received September 27, 1996

    Report

    Report Number
    1618732-1996-00035
    Event Type
    Injury
    Date Received
    September 27, 1996
    Date of Event
    June 3, 1996
    Report Date
    September 5, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 11/15/96H6 - ADDITIONAL DATA CORRECTED DATA DEVICE CODE 1069 - LABELEDWITHOUT A LOT NUMBER OR SAMPLE, WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE INCIDENT REPORTED. WE WILL HOWEVER CONTINUE TO TRACK THIS TYPE OF INFORMATION, AS IT IS IMPORTANT TO OUR PRODUCT IMPROVEMENT AND DEVELOPMENT PROCESS.

    Description of Event or Problem · 1

    MEDICAL INTERVENTION WAS REQUIRED TO REMOVE A CATHETER INSERTED ON 4/5/96. TWO IV TEAM NURSES ATTEMPTED TO REMOVE THE DEVICE WITHOUT SUCCESS. THE SECOND RN WAS "MORE AGGRESSIVE" IN ATTEMPTING TO DISCONTINUE THE CATHETER. HE WAS ABLE TO REMOVE 12 INCHES BEFORE MEETING RESISTANCE. THE PT WAS THEN SENT TO THE RADIOLOGY DEPT. FLUOROSCOPIC GUIDED REMOVAL WAS ATTEMPTED, DURING THE PROCEDURE" THE CATHETER BROKE AT THE HUB". THE PT BECAME DIAPHORETIC AND DEVELOPED TACHYCARDIA. A SECOND PROCEDURE, UNDER FLUOROSCOPIC GUIDANCE, THE DEVICE WAS RETRIEVED FROM THE PULMONARY ARTERY INTACT. THE PT WAS DIAGNOSED WITH PULMONARY EMBOLUS, TRANSFERRED FROM THE RADIOLOGY DEPT TO THE CORONARY CARE UNIT AND STARTED ON HEPARIN THERAPY. THE PT WAS LATER DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTERMARK PERIPHERALLY INSERTED CENTRAL CATHETER/EXACT CODE PERIPHERALLY INSERTED CENTRAL CATHETER DQO MENLO CARE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R GENTAMYCIN AMOUNT AND FREQUENCY NOT AVAILABLE| VANCOMYCIN AMOUNT AND FREQUENCY NOT AVAILABLE