BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOMED RADIOPAQUE, SILICONE UMBILICAL CATHETER

    MDR report key: 3672898 · Received February 21, 2014

    Report

    Report Number
    3006520777-2014-00001
    Event Type
    Death
    Date Received
    February 21, 2014
    Date of Event
    December 30, 2013
    Report Date
    February 20, 2014
    Manufacturer
    NEOMED INC.
    Product Code
    FOS
    PMA / PMN Number
    K081515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE MEDWATCH FILED BY (B)(6) ((B)(6) 2014), NEOMED IMMEDIATELY REVIEWED DISTRIBUTION RECORDS TO DETERMINE THE POTENTIAL LOT NUMBERS OF THE DEVICE IN QUESTION, INFORMED THE PRODUCTION MANAGER TO BEGIN THE DHR REVIEW OF ALL POTENTIAL LOTS, CONTACTED OUR MEDICAL ADVISOR (NEONATOLOGIST) FOR CLINICAL INPUT, AND CONTACTED THE HOSPITAL RISK MANAGER TO REQUEST A MEETING. ALL POTENTIAL LOT NUMBERS' DHRS WERE REVIEWED AND CONFIRMATION WAS PROVIDED THAT ALL LOTS MET ALL SPECS AND THERE WERE NO NONCONFORMITIES ASSOCIATED WITH THE PRODUCTION OF ANY OF THESE OTS. A FACE TO FACE MEETING WAS SCHEDULED WITH THE HOSPITAL RISK MGR FOR (B)(4) 2014; HOWEVER, WAS RESCHEDULED TO (B)(4) 2014 DUE TO INCLEMENT WEATHER. NEOMED'S DIRECTOR OF QA/RA AND QA ASSOCIATE MET WITH THE RISK MGR ON (B)(4) 2014 AND DISCUSSED THE DETAILS OF THIS INCIDENT AND OBTAINED THE DEVICE IN QUESTION FOR EVAL. THE COMPLAINT DEVICE WAS PROVIDED INTACT. THE DEVICE SHOWED NO PHYSICAL SIGNS OF MALFUNCTION. THE TIP OF THE DEVICE WAS REVIEWED UNDER MICROSCOPY AND DID NOT SHOW ANY SIGNS OF DEFECT. THE DISTAL TIP OF THE CATHETER WAS SMOOTH WITHOUT ANY SIGNS OF DAMAGE OR SHARP EDGES. THE MEETING WITH THE HOSPITAL RISK MGR OBTAINED ADD'L INFO, AS WELL AS UVC WAS PLACED AT 7CM AND UAC AT 12.5CM BY NP. THE UVC WAS PLACED ON FIRST ATTEMPT WITHOUT DIFFICULTY. DUE TO POTENTIAL SKIN IRRITATION CONCERNS, THE EXTERNAL TO THE BODY PORTION OF THE UVC WAS NOT SECURED WITH TAPE. MEDS WERE DELIVERED THROUGH UAC AND TPN THROUGH UVC. TPN=82MG/KG PER DAY. ON (B)(6) 2013, AROUND MIDNIGHT, NURSE NOTICED DISTENDED ABDOMEN. ABDOMINAL X-RAY TAKEN AT 2AM AND SHOWED UVC AT T9 (ORIGINALLY T8). THEREFORE, AT 5:14AM, A NOSE TO RECTUM X-RAY WAS PERFORMED AND SHOWED LUCENCY AT T9 WHICH RADIOLOGIST DOCUMENTED WAS REPRESENTATIVE OF A CONFINED PERFORATION. UVC WAS REMOVED, UAC WAS NOT. A CONTRAST STUDY CONFIRMED PERFORATION. AFTER OUR MEDICAL ADVISOR'S REVIEW OF THE ON-SITE HOSPITAL MEETING MINUTES, WE HAVE REQUESTED ADDITIONAL INFO. WE HAVE MADE THREE ATTEMPTS TO OBTAIN THIS INFO AND ARE AWAITING RESPONSE FROM THEIR LEGAL DEPT. AT THIS TIME, NO CORRECTIVE ACTIONS WILL BE TAKEN, AS THE EVAL OF THE DHRS AND THE DEVICE EVAL DO NOT INDICATE A DEVICE MALFUNCTION. NEOMED'S MEDICAL ADVISOR REVIEW ALSO DOES NOT SUGGEST A DEVICE MALFUNCTION. THE RISK MANAGER ALSO COMMUNICATED THAT THE HOSPITAL DOES NOT THINK THAT THE DEVICE MALFUNCTIONED.

    Description of Event or Problem · 1

    ON (B)(4) 2014, NEOMED RECEIVED VIA MAIL, A COPY OF A MEDWATCH FILED BY (B)(6). THE MEDWATCH STATED: "INFANT (B)(6) GESTATION BORN WEIGHING (B)(6) ON (B)(6) 2013. UMBILICAL VENOUS AND ARTERIAL CATHETERS PLACED AT BIRTH FOR TREATMENT. ON (B)(6) 2013 EVENING, INFANT WENT INTO SHOCK. UMBILICAL VENOUS CATHETER SUSPECTED TO HAVE PERFORATED LIVER. INFANT CONFIRMED TO HAVE HEMOPERITONEUM, CATH (VENOUS) REMOVED. INFANT HAD INCREASED OXYGEN NEEDS, COAGULOPATHY, METABOLIC ACIDOSIS. INFANT EXPIRED (B)(6) 2013."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109311 NOMED RADIOPAQUE, SILICONE UMBILICAL CATHETER UMBILICAL VESSEL (VENOUS) CATHETER FOS NEOMED INC. S2UVC4.0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Death