BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTROCAN

    MDR report key: 12488065 · Received September 17, 2021

    Report

    Report Number
    9610825-2021-00389
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    August 26, 2021
    Report Date
    October 22, 2021
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    DQR
    UDI-DI
    04046964478673
    PMA / PMN Number
    K982805
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). SINCE NO SAMPLE HAS BEEN PROVIDED FOR INVESTIGATION WE COULD NOT CONFIRM ANY MALFUNCTIONS OR DETERIORATION IN THE CHARACTERISTICS OR PERFORMANCE OF A DEVICE. BASED ON THE PROVIDED PICTURES A FINAL ASSESSMENT FOR THE ROOT CAUSE IS NOT POSSIBLE. AN USE ERROR CANNOT BE EXCLUDED AT THE CURRENT TIME POINT. AS COMMUNICATED IN IFU, WARNING SECTION STATED THAT: AFTER WITHDRAWAL, DO NOT REINTRODUCE THE STEEL NEEDLE INTO THE CATHETER, AS THE LATTER MAY BE CUT OFF, LEADING TO CATHETER EMBOLISM. THE 100% IN-LINE VISION SYSTEM IS ABLE TO DETECT NON-CONFORMING PRODUCTS. IN THE BATCH RECORDS NO ABNORMALITIES WERE NOTED. THEREFORE THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED, AS SOON AS INVESTIGATION HAS BEEN COMPLETED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "BROKEN DEVICE" "CUSTOMER REPORT SERIOUS ADVERSE EVENT WITH CATHETER PERIFERIC. PATIENT WITH VERY DIFFICULT VENOUS ACCESS, IN HIS 11TH DAY OF HOSPITAL STAY, WHO TODAY ON (B)(6) 2021 IN THE EARLY HOURS OF THE MORNING (00: 03) MANIFESTED NO PERMEABILITY OF THE PERIPHERAL VENOUS CATHETER, SO AUXILIARY NURSE ON DUTY PERFORMS REMOVAL OF THIS AND CHANGE, AFTER ASEPTIC TECHNIQUE WITH CHLORHEXIDINE + SALINE SOLUTION 0.9% PERFORMS VENIPUNCTURE IN ONE ATTEMPT, IN THE PROXIMAL THIRD OF THE RIGHT FOREARM, THE ACCESS WAS CHECKED FOR PATENCY, AND THE PATIENT MANIFESTED PAIN AT THE VENIPUNCTURE SITE DURING THE MORNING SHIFT OF THE SAME DAY ON (B)(6) 2021, SO THE ASSISTANT ON DUTY, AFTER THE FIRST ATTEMPT, PLACED A HEPARINIZED PLUG AND FIXED IT WITH MICROPORE WITHOUT ANY COMPLICATION, SO AUXILIARY ON DUTY AFTER ASEPTIC TECHNIQUE PERFORMS REMOVAL OF THIS, SHOWING THAT CATHETER REMAINS IN THE INTRAVENOUS LINE, REMOVING ONLY CONE CATHETER CONNECTION PLUS HEPARINIZED CATHETER, PRESSURE IS APPLIED, FIXED WITH MICROPORE, THE GENERAL PHYSICIAN ON DUTY IS IMMEDIATELY INFORMED, WHO IN TURN INFORMS THE VASCULAR SURGEON FOR ASSESSMENT AND REMOVAL OF THE CATHETER, THE PATIENT'S SAFETY IS NOTIFIED, THE PATIENT IS HEMODYNAMICALLY STABLE, NO VENOUS ACCESS IS LEFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385517 INTROCAN I.V. SAFETY CATHETER DQR B. BRAUN MELSUNGEN AG 4251601-020 20M11G8301 04046964478673

    Patients

    Seq Age Sex Outcome Treatment
    1 Other