BEUDAMED
    FDA Adverse Event Death Summary report: N

    NIPRO HYPODERMIC NEEDLE

    MDR report key: 4935227 · Received July 23, 2015

    Report

    Report Number
    8041145-2015-00060
    Event Type
    Death
    Date Received
    July 23, 2015
    Date of Event
    May 5, 2015
    Report Date
    July 22, 2015
    Manufacturer
    NIPRO THAILAND CORPORATION LTD
    Product Code
    FMI
    PMA / PMN Number
    K944355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER INVESTIGATION REPORT ON RETAINED SAMPLES ONLY.

    Description of Event or Problem · 1

    INCIDENT OCCURRED ON (B)(6) 2015, DURING PROCEDURE DOCTOR USED THE NEEDLE TO INJECT XYLOCAINE 2% INTO THE LEFT BACK SIDE OF THE FEMALE PATIENT WITH STAGE 4 (FINAL STAGE) LUNG CANCER, IN ORDER TO INSERT THE TUBE TO THE LUNG, THE NEEDLE DETACHED FROM THE HUB AND REMAINED IN THE PATIENT'S BODY. DOCTOR TRIED TO REMOVE IT BY SURGERY, BUT WAS UNABLE TO REMOVE THE NEEDLE. THEREAFTER, SHE HAD AN X-RAY AND FOUND THAT THE NEEDLE STILL REMAINED INSIDE THE BODY. PATIENT PASSED AWAY. HER RELATIVE CLAIMED THE NEEDLE WAS THE CAUSE OF DEATH OF THE PATIENT. PRODUCT LOT NUMBER WAS NOT SPECIFIED AND HOSPITAL DISCARDED THE SAMPLE NEEDLE. POSSIBLE RELATED LOTS: 15A28 & 15B26. (B)(6) 2015:NIPRO SALES REPRESENTATIVE AND DISTRIBUTOR'S STAFF WENT TO THE HOSPITAL AND MET WITH DR. ARLI AND NURSE(HEAD OF MEDICINE WARD). DCOTOR EXPLAINED THAT THE PATIENT WAS ADMITTED TO THE MEDICINE WARD WITH STAGE 4 LUNG CANCER ON LEFT LUNG, AFTER X-RAY WAS PERFORMED, DCOTOR FOUND THAT PATIENT HAD FLUID ON LEFT PLEURAL, DOCTOR ORDERED TO DRAIN FLUID FROM LEFT PLEURAL, STARTED PROCEDURE BY INSERTING TUBE INTO THE LESION (PLEURAL), THEN DOCTOR INJECTED XYLOCAINE 2% ABOVE THE RIB ON LEFT SIDE OF BACK, CANNULA BROKE OFF FROM THE HUB AND REMAINED INSIDE THE PATIENT'S BODY. DOCTOR AND SURGEON CONSULTED TO OPEN LESION TO REMOVE CANNULA, BUT WERE UNABLE TO FIND THE CANNULA. PATIENT WAS SENT TO HAVE AN X-RAY AND CONFIRMED THE CANNULA REAMINED ON LEFT PLEURAL OF PATIENT. DOCTOR SPOKE WITH THE PATIENT'S RELATIVE AND ADVISED OF THE SITUATION, THEY UNDERSTOOD AND ACCEPTED.AFTER 22 DAYS OF ADMISSION IN THE HOSPITAL, PATIENT WAS NOT RESPONDING WELL TO THE TREATMENT, DOCTOR ADVISED THE RELATIVE OF THE PATIENT OF THE SITUATION AND ADVISED TO BE DISCHARGED HOME. PATIENT'S RELATIVE REQUESTED FOR DOCTOR TO COMPENSATE FOR MEDICAL ERROR. HOSPITAL AND DOCTOR REQUESTED DISTRIBUTOR TO INVESTIGATE ON CANNULA PRODUCT QUALITY. DOCTOR WAS NOT SATISFIED WITH EXPLANATION FROM NIPRO SALE REP, REQUESTED INVESTIGATION REPORT FORM FACTORY. MEETING SCHEDULED FOR (B)(6) 2015 TO DISCUSS FINDINGS. DATA COLLECTED, AND REPORTED TO MANAGEMENT OF COMPANY. NTC QA DEPARTMENT MANAGER AND NIPRO SALES REPRESENTATIVE VISITED THE HOSPITAL ON (B)(6) 2015, SPOKE WITH DOCTOR (VICE DIRECTOR) AND THE DOCTOR PROPOSED TO MEASURE LENGTH OF NEEDLE ON X-RAY FILM, RESULTS IN LATERAL VIEW SHOWED THAT THE NEEDLE WAS BENT MORE THAN 45 DEGREES. BASED ON THESE FINDINGS, INVESTIGATION INDICATED THAT THE NEEDLE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480663 NIPRO HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI NIPRO THAILAND CORPORATION LTD 24GX1.1/2"

    Patients

    Seq Age Sex Outcome Treatment
    1 Death