BEUDAMED
    FDA Adverse Event Death Summary report: N

    V-CATH PICC 3.0F

    MDR report key: 1962490 · Received January 8, 2011

    Report

    Report Number
    2925153-2011-00001
    Event Type
    Death
    Date Received
    January 8, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 4, 2011
    Manufacturer
    NEO MEDICAL, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REVIEW MEDWATCH REPORT INCLUDED FROM (B)(6) CHILDREN'S HOSPITAL # (B)(6). NEO MEDICAL'S (B)(4) RECEIVED A CALL ON (B)(6) 2010 FROM COMPLAINANT INFORMING NEO MEDICAL THAT A MEDWATCH REPORT WAS BEING FILED WITH FDA AND A COPY SENT TO NEO MEDICAL AS REQUIRED DUE TO A PT EXPIRING WHILE A DEVICE MANUFACTURED BY NEO MEDICAL WAS IN USE. COMPLAINT COMMITTEE CONDUCTED A REVIEW OF THE FACILITY PROVIDED MEDWATCH REPORT. TWO DIFFERENT MANUFACTURER DEVICES WERE BEING USED. ONE FROM NEO MEDICAL, THE OTHER MFG UNK. IT WAS INCONCLUSIVE AS TO WHETHER EITHER DEVICE IN USE WAS THE CAUSE OF THE ADVERSE EVENT. THE REPORT PROVIDED BY FACILITY, NOTED THAT BOTH DEVICES MAY HAVE BEEN PLACED INCORRECTLY. COMPLAINANT STATED DURING THE PHONE CONVERSATION ON (B)(6) 2010 THAT IT WAS UNDETERMINED IF THE UVC OR PICC LINE WAS THE CAUSE OF THE ADVERSE EVENT. ALSO MENTIONED WAS THAT THE DEVICES DID NOT MALFUNCTION BASED ON INDICATED USE. COMPLAINT COORDINATOR REQUESTED THE DEVICE 3081-1660 BE RETURNED FOR EVAL. COMPLAINANT STATED THAT BOTH THE UVC AND PICC LINE DEVICES WERE DISCARDED. (B)(4). ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: INFANT BORN AT (B)(6) WITH HYPOPLASTIC LEFT HEART, VSD, DORV, AORTIC ARCH ANOMALY AND LARGE PDA. UVC PLACED ON (B)(6) 2010 FOR IVF AND PGE AT OUTLYING FACILITY. UPON TRANSFER TO NICU UVC DOCUMENTED AT 8.5CM. ON (B)(6) 2010, SINGLE LUMEN PICC LINE PLACED TO RIGHT SAPHENOUS. FINAL LENGTH OF INTERNAL CATHETER 24.5CM. ON (B)(6) 2010, CHEST X-RAY 1 VIEW ON (B)(6) 2010 SHOWED THE UVC IN THE HEART PERHAPS THE RIGHT VENTRICLE. UVC PULLED BACK TO 6CM. ON (B)(6) 2010, CHEST/ABD X-RAY COMBINED SHOWED PICC LINE WITH TIP AT T10 LEVEL. PICC LINE PULLED BACK 4CM TO 20.5CM. ON (B)(6) 2010, PT TO OPERATING ROOM FOR NORWOOD PROCEDURE. UPON OPENING THE PERICARDIUM, THERE WAS ABOUT 10CC OF SEROUS FLUID, SLIGHTLY BLOOD TINGED. THERE WAS A MODEST HEMATOMA TO THE ANTERIOR SURFACE OF THE RV WHICH MEASURED ABOUT THE SIZE OF A DIME. AFTER REPAIR COMPLETE, THE HEMATOMA ON THE ANTERIOR SURFACE OF THE RV HAD SPREAD TO THE LATERAL WALL AND ALL THE WAY TO THE ATRIAL SEPTUM. THERE WAS NO FUNCTION IN THE AREA OF THE HEMATOMA. PT COULD NOT COME OFF BYPASS AFTER MULTIPLE ATTEMPTS. FAMILY ELECTED NOT TO GO ON ECMO TO BRIDGE TO TRANSPLANT. PT EXPIRED (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC 3.0F PERIPHERALLY INSERTED CENTRAL CATHETER LJS NEO MEDICAL, INC. 3081-1660 1004

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Other