BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17815789 · Received September 26, 2023

    Report

    Report Number
    2243072-2023-01717
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 30, 2023
    Report Date
    October 27, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED THE ADAPTER WITHOUT THE CATHETER TUBING ATTACHED, VERIFYING THE REPORTED INCIDENT. NO PHOTOS OF THE CATHETER TUBING WERE PROVIDED. INITIAL REPORT FROM CUSTOMER INDICATES ACTUAL LOT INVOLVED WAS UNKNOWN. A PHOTO WAS PROVIDED OF THE DISPENSER BOX WITH A LOT CODE. IT COULD NOT BE CONFIRMED WITH THE CUSTOMER IF THAT LOT WAS INVOLVED IN THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR LOT, 3124034, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. CONTROLS ARE USED DURING MANUFACTURING TO DETECT DAMAGE TO THE DEVICE, NO ISSUES WERE FOUND RELATED TO THIS INCIDENT. BASED ON THE SAMPLE EVALUATION AND OUR QUALITY TEAM'S INVESTIGATION, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME. SEE MANUFACTURER NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. 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 WHILE USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETER SEPARATED FROM THE HUB. THE FOLLOWING WAS TRANSLATED FROM ITALIAN TO ENGLISH: "THE CANNULA NEEDLE WAS POSITIONED ON (B)(6) 2023 IN THE LEFT LOWER LIMB. ON (B)(6) 23 THE PATIENT, DISORIENTED AND IN A STATE OF AGITATION, SELF-REMOVES THE CVP FROM THE MINISTRY OF HEALTH DISPOVIGILANCE, THE OPERATOR IMMEDIATELY ARRIVES IN THE ROOM, HAVING BEEN CALLED BY THE PATIENT NEXT TO THE BED WHO NOTICED WHAT HAD HAPPENED. DURING THE INSPECTION THE OPERATOR IMMEDIATELY NOTICES THE LACK/ABSENCE OF THE CANNULA FROM THE CANNULA NEEDLE INLET CONE. THE ROOM IS THOROUGHLY INSPECTED TO NO AVAIL. IMMEDIATELY REPORTED TO THE DOCTOR ON CALL WHO NOTES THE INCIDENT IN THE MEDICAL RECORD; AN IMMEDIATE EVALUATION WAS CARRIED OUT ON THE LIMB WHICH SHOWED NO SIGNS OF INFLAMMATION AND PAIN, AND THERE WAS GOOD PERFUSION. CONTACTED ON (B)(6) 2023 DR. FROM RADIOLOGY WHO CONFIRMED "SUPERFICIAL VEIN WITH SMALL ENDOLUMINAL HYPERDENSE DEFECT ELONGATED BY APPROXIMATELY 1 CM"; BY TELEPHONE CONFIRMS ECD AS THE BEST INVESTIGATION METHOD WHICH IS CARRIED OUT ON (B)(6) 2023 BY THE VASCULAR SURGEON (B)(6). THE REPORT REPORTS NO CURRENT VASCULAR SURGICAL INDICATION, NO APPRECIABLE FOREIGN BODIES ON PALPATION BUT PRESENTS PHLEBITIS OF THE VEIN EXTENDED FOR APPROXIMATELY 15 CM. EPBM THERAPY BASED ON WEIGHT AND RENAL EFFECT. PATIENT ON (B)(6) 2023 STILL HOSPITALIZED AND STABLE, NEEDLE CANNULA NOW POSITIONED ON RIGHT FOREARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440582 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Unknown Required Intervention