BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERMARK PERIPHERALLY INSERTED CENTRAL CATHETER W/17G

    MDR report key: 38647 · Received September 13, 1996

    Report

    Report Number
    1618732-1996-00016
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    August 12, 1996
    Report Date
    August 15, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 10/11/96. H2 JOHNSON & JOHNSON MEDICAL, INC. HAS DECIDED TO DISCONTINUE MFR AND SALE OF THE STREAMLINE, LANDMAKS AND CENTERMARK BANDS OF I.V. CATHETERS AS OF 9/18/96.

    Description of Event or Problem · 1

    A THIRD ATTEMPT TO INSERT THE DEVICE INTO AN APPREHENSIVE PT WAS SUCCESSFUL AND WAS THREADED THE FULL LENGTH. A FLUSH OF NORMAL SALINE AND HEPARINIZED SALINE WAS USED. AS THE INSERTION WAS COMPLETED, THE PT REPORTED SHORTNESS OF BREATH AND A FEELING OF FULLNESS IN HIS CHEST. PT WAS PLACED ON A CARDIAC MONITOR (BRADYCARDIA). PT TOLD CLINICIAN THAT HEART RATE NORMALLY RUNS LOW. OXYGEN WAS APPLIED VIA NASAL CANNULA. SAO2 WAS 95%. RESPIRATORY RATE WAS 18-20. PHYSICIAN WHO SAW THE PT RECOMMENDED THAT THE DEVICE BE REMOVED. CLINICIAN DID NOT WANT TO REMOVE THE DEVICE BECAUSE OF THE DIFFICULTY INSERTING THE DEVICE. THE DEVICE WAS PULLED BACK 4 INCHES BECAUSE OF THE POSSIBILITY OF BEING IN THE RIGHT ATRIUM. PT GIVEN PO BENADRYL. EKG REVEALED SINUS BRADYCARDIA. A PERIPHERAL IV WAS INSERTED. WITHIN 15 MINUTES PT WALKED TO X-RAY TO CONFIRM PLACEMENT IN THE TOP OF THE SVC. THE DEVICE REMAINED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTERMARK PERIPHERALLY INSERTED CENTRAL CATHETER W/17G PERIPHERALLY INSERTED CENTRAL CATHETER FOZ MENLO CARE, INC. NA 503241

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CAT SCAN WITH A REACTION TO THE DYE A FEW HOURS| PREVIOUSLY. HEPARINIZED SALINE FLUSH.