BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 12921159 · Received December 2, 2021

    Report

    Report Number
    9610048-2021-00159
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    January 12, 2022
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-12-22. H6: INVESTIGATION SUMMARY: BD RECEIVED A 22 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 1211738 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND CONFIRMED THAT A PIECE OF THE CATHETER WAS STILL PRESENT INSIDE OF THE ADAPTER BUT THE REMAINING PORTION OF THE CATHETER WAS MISSING. A PHOTO OF THE DEFECT WAS ALSO PROVIDED AND CONFIRMED THE FINDINGS OF THE VISUAL EXAMINATION. BASED OFF THE PROVIDED PHOTO AND VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THAT THE CATHETER DID BREAK AND BROKE AFTER PLACEMENT DUE TO THE PRESENCE OF FLUID VISIBLE IN THE PHOTO. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE ENGINEER COULD DETERMINE THAT IT WAS NOT A MANUFACTURING ISSUE AS IF IT HAD BEEN MANUFACTURING RELATED THE DEVICE WOULD NOT HAVE BEEN ABLE TO BE USED.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS FOUND DAMAGED WHEN REMOVED FROM THE PATIENT, AND PART OF THE CATHETER HAD BROKEN OFF INSIDE THE VEIN. DOPPLER AND MSE ULTRASOUND WAS USED TO VERIFY THE POSITION OF THE BROKEN PIECE, FOLLOWED BY VASCULAR EVALUATION AND HEMODYNAMIC INTERVENTION TO REMOVE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WHEN REMOVING THE ACCESS, IT WAS IDENTIFIED THAT THE DEVICE WAS BROKEN. ACCORDING TO REPORT, MATERIAL HAD PROBLEMS DURING USE." " WAS A PORTION OF THE CATHETER FOUND TO REMAIN IN THE PATIENT'S VEIN? OR WAS IT JUST OBSERVED ITS BREAKUP? THE PORTION OF THE CATHETER REMAINED INSIDE THE PATIENT. WAS THERE ANY IMPACT ON THE PATIENT? (DETAIL) THERE WAS A NEED FOR HEMODYNAMIC INTERVENTION TO REMOVE A "FOREIGN BODY" FROM INSIDE THE PATIENT'S VEIN. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? (DETAIL) IT IS NECESSARY TO PERFORM DOPPLER AND MSE ULTRASOUND TO VERIFY THE POSITION OF THE FOREIGN BODY AND EVIDENCE OF THE OCCURRENCE AND VASCULAR EVALUATION. PROCEDURE IN THE HEMODYNAMICS SECTOR."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS FOUND DAMAGED WHEN REMOVED FROM THE PATIENT, AND PART OF THE CATHETER HAD BROKEN OFF INSIDE THE VEIN. DOPPLER AND MSE ULTRASOUND WAS USED TO VERIFY THE POSITION OF THE BROKEN PIECE, FOLLOWED BY VASCULAR EVALUATION AND HEMODYNAMIC INTERVENTION TO REMOVE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WHEN REMOVING THE ACCESS, IT WAS IDENTIFIED THAT THE DEVICE WAS BROKEN. ACCORDING TO REPORT, MATERIAL HAD PROBLEMS DURING USE." "WAS A PORTION OF THE CATHETER FOUND TO REMAIN IN THE PATIENT'S VEIN? OR WAS IT JUST OBSERVED ITS BREAKUP? THE PORTION OF THE CATHETER REMAINED INSIDE THE PATIENT. WAS THERE ANY IMPACT ON THE PATIENT? (DETAIL) THERE WAS A NEED FOR HEMODYNAMIC INTERVENTION TO REMOVE A "FOREIGN BODY" FROM INSIDE THE PATIENT'S VEIN. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC)? (DETAIL) IT IS NECESSARY TO PERFORM DOPPLER AND MSE ULTRASOUND TO VERIFY THE POSITION OF THE FOREIGN BODY AND EVIDENCE OF THE OCCURRENCE AND VASCULAR EVALUATION. PROCEDURE IN THE HEMODYNAMICS SECTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817556 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381823 1211738 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention