BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURSHIELD PUR SAFETY I.V. CATHETER

    MDR report key: 7142873 · Received December 22, 2017

    Report

    Report Number
    9681835-2017-00044
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 25, 2017
    Manufacturer
    TERUMO CORPORATION - KOFU
    Product Code
    FOZ
    PMA / PMN Number
    K100282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVED WAS A CANINE; IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED: BASED OFF THE ACTUAL DEVICE UNAVAILABLE TO BE EVALUATED, NO FAILURE DETECTED: BASED OFF THE RESERVE SAMPLE EVALUATED. THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. RETENTION SAMPLES WERE OBSERVED AND NO ANOMALIES WERE FOUND WITH THE NEEDLE TIP, AND THERE WAS NO CONTAMINATION INSIDE THE NEEDLES. PENETRATION RESISTANCE CHECK WAS PERFORMED. A POLYETHYLENE SHEET WITH 50-MICRON THICKNESS WAS USED FOR INSERTION RESISTANCE AND WAS MEASURED, WITH VALUES WITHIN MANUFACTURER SPECIFICATION. A REVIEW OF THE MANUFACTURER INSPECTION RECORD OF THE INVOLVED LOT NUMBER REVEALED NO RELEVANT FINDINGS. THE CORRESPONDING PRODUCT TYPE HAS BEEN TESTED IN ACCORDANCE WITH ISO (B)(4) SAFETY INSPECTION (BIOLOGICAL EVALUATION OF MEDICAL DEVICE). TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF KOFU FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681835. EXEMPTION NUMBER E2015026.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A NEEDLE PUNCTURE WITH THE INVOLVED DEVICE AFTER A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: AFTER THE SURFLOW HAD REACHED INTO THE VEIN, IT WAS NOT REMOVED AS INTENDED. WHEN THE HEALTH CARE PROFESSIONAL ATTEMPTED TO PLACE THE CATHETER IN THE VESSEL, BLOOD FLASHBACK WAS VISUALLY CONFIRMED IN THE FLASHBACK CHAMBER BUT IT WAS POOR. THE SURFLOW WAS SLIGHTLY ADVANCED FURTHER INTO VEIN. WHEN ANOTHER BLOOD FLASHBACK WAS OBSERVED, THE HEALTH CARE PROFESSIONAL THEN ATTEMPTED TO SECURE THE CATHETER-HUB. DUE TO EMERGED SYMPTOMS OF SWELLING CAUSED BY INTERNAL BLEEDING, THE HEALTH CARE PROFESSIONAL GUESSED THAT IT HAD LEAKED UNDER SKIN. SHORTLY AFTER, AS THEY ATTEMPTED TO REMOVE IT FROM THE PATIENT, IT WAS UNABLE TO BE REMOVE. THE PATIENT LATER SUFFERED A PAINFUL SENSATION, A DOCTOR WAS CALLED FOR ASSISTANCE. THE ATTENDING DOCTOR SUCCESSFULLY REMOVED THE SURFLO AFTER INJECTING LOCAL ANESTHESIA. NO FURTHER PAIN WAS SUFFERED AND THE CURRENT CONDITION OF THE PATIENT IS FINE. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED DEVICE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE CORRECTIONS. THE ADDRESS NAME AND ADDRESS WAS INADVERTENTLY REPORTED AS "(B)(6)" IT HAS BEEN CORRECTED TO (B)(6). PMA/510K WAS INITIALLY REPORTED K082362, THE CORRECT NUMBER IS K100282.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921578 SURSHIELD PUR SAFETY I.V. CATHETER INTRAVASCULAR CATHETER FOZ TERUMO CORPORATION - KOFU NA 170904S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R