BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELDINGER CENTRAL VENOUS CATHETER

    MDR report key: 311676 · Received January 8, 2001

    Report

    Report Number
    8020616-2000-00005
    Event Type
    Injury
    Date Received
    January 8, 2001
    Report Date
    December 28, 2000
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE USER HAD 2 ANAPHYLACTIC SHOCKS DURING A GENERAL ANESTHESIA AFTER THE INSERTION OF CVC HYDROCATH WITH 2 PEDIATRIC PTS. THESE 2 EVENTS HAPPENED IN OPERATING THEATRE OF NEUROSURGERY IMMEDIATELY AFTER THE POSITIONING OF HYDROCATH. THE 2 PEDIATRIC PTS RECEIVED GENERAL ANESTHESIA. NO PROBLEM WITH THE INDUCTION OF THE GENERAL ANESTHESIA WITH MIDAZOLAM, FENTANEST, PACURONIO, FORANE, N2O/O2, MECHANICAL VENTILATION WITH PREVIOUS INTUBATION ORO-TRACHEAL. AFTER 20 MINUTES FROM INDUCTION OF THE GENERAL ANESTHESIA, AFTER THE POSITIONING OF THE CVC HYDROCATH (WITHOUT ANY PROBLEM) THE USER INJECTED A SALINE SOLUTION FOR FLUSHING THE CATHETER. AFTER THIS THE USER OBSERVED AN INCREASE OF ENDOTRACHEAL PRESSURE AND THE APPEARANCE OF DIFFUSED CUTANEOUS RUSH IN ALL THE BODY OF THE PT AND STATE OF SHOCK. THE USER IMMEDIATELY ADMINISTERED CORTISONE AND PERFORMED A MANUAL VENTILATION, WITH FILING OF PLASMA EXPANDERS, INFUSION OF DOPAMINA AND COGLUNATO. AFTER 10-15 MINUTES THE PT HAD AN ACCEPTABLE HEMODYNAMIC SITUATION AND THE DISAPPEARING OF THE CUTANEOUS RUSH. WHEN THE PT WAS STABILIZED THE SURGEON MADE THE INTERVENTION WITHOUT MORE PROBLEMS.

    Description of Event or Problem · 1

    BEFORE THE EVENT, THE DEVICE WAS USED WITH RIGHT FEMORAL APPROACH WITH THE POSITIONING OF THE TIP OF THE CATHETER ON JUNCTION INFERIOR CAVE VEIN AND RIGHT ATRIUM. CREATION OF SERILE FIELD WITH PREPARATION OF THE SITE WITH AN ANTISEPTIC SOLUTION NEOMEDIL (CO:FARMEC-COMPOSITION: 2.5% BZC, ALCOHOL ETHYLIC 95 DEGREE, OTHER EXCIPIENTS). DURING THE INSERTION THE CATHETER WAS EXTERNALLY WET WITH SALINE SOLUTION IN ORDER TO ACTIVATE THE HYDROMER FOR A BETTER INSERTION. THE INSIDE LUMEN OF THE CATHETER WAS NOT FLUSHED BEFORE THE INSERTION TO PT. OTHER DEVICES USED DURING EVENT: IV CATHETER FOR PERIPHERAL VEIN (BD VENFLON), ENDOTRACHEAL TUBE (MALLINCKRODT), ELECTRODES FOR ECG MONITORING (RED DOT-3M), RADIOLUS NASOGASTRIC (PORTEX) AND PLASTER FOR MONITORING WITH SATURIMETER INSTRUMENTS, 10ML PLASTIC SYRINGE (ARTSANA) AND 10ML SALINE SOLUTION (SODIUM CHLORIDE 0.9%-FRESENIUS KABI). DEVICE WAS USED FOR 1 MIN ON PT BEFORE THE REACTION WAS SEEN. REACTION WAS SEEN IMMEDIATELY AFTER 1 MIN THE ANAESTHETIST OBSERVED AN INCREASE OF ENDOTRACHEAL PRESSURE, RUSH CUTNEOUS BEFORE ON THE FACE AND AFTER DIFFUSED ON ALL THE BODY OF THE PT AND HYPOTENSION. THE USER IMMEDIATELY ADMINISTERED CORTISONE AND HE PERFORMED A MANUAL VENTILATION, WITH FILLING OF PLASMA EXPANDERS, INFUSION OF DOPAMINE AND COGLUNATE - IN THIS CASE, DR ADMINISTERED THROUGH THE CATHETER ONLY STEROIDS - BENTELAN 1.5MMG/1ML. THE CATHETER WAS NOT REMOVED IMMEDIATELY WHEN THE REACTION WAS OBSERVED. THE PERMANENCE OF THE CATHETER WAS OF 72 HRS. INVESTIGATION REVEALED THE FOLLOWING: THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT MADE AVAILABLE TO BD SO IT WAS NOT POSSIBLE FOR US TO CONDUCT SPECIFIC EXAMINATION AND TESTING. REVIEW OF THE LOT MFG AND TEST RECORDS INDICATE THAT THE ENTIRE LOT QUANTITY OF 1200 PRODUCTS MET SPEC AND CO CAN CONFIRM THAT CO HAS RECEIVED NO SIMILAR REPORTS RELATING TO THIS LOT FROM USER FACILITIES. BD HAS FULLY VALIDATED THE BIOCOMPATIBILITY OF THE HYDROCATH CATHETER IN ACCORDANCE WITH ISO 10993, AND HAS PERFORMED ADD'L TOXICOLOGICAL TESTING, WHICH HAS ALSO CONFIRMED THE SUITABILITY OF THE HYDROCATH CATHETER. CO SHALL CONTINUE TO CLOSELY MONITOR AND EVALUATION CLINICAL EXPERIENCE, AS APPROPRIATE. REVIEW OF PAST SIMILAR EVENTS HAS BEEN UNABLE TO PROVIDE EVIDENCE DIRECTLY LINKING THE USE OF THE CATHETER AND THE REACTIONS SEEN ON PT. GIVEN THE CASE REPORTS AND KNOWING THE POTENTIAL CAUSES OF ANAPHYLACTIC REACTION, AND SINCE ACTUAL COMPLAINT DEVICE WERE NOT AVAILABLE, THE CO IS UNABLE TO CONCLUDE THAT THE REACTION REPORTED WAS DUE TO THE CATHETER. NO FURTHER INFO WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679 SELDINGER CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER FOZ BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. HYDROCATH ONE LUMEN 908199

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention