BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN INTROCAN SAFETY IV CATHETER

    MDR report key: 9586160 · Received January 13, 2020

    Report

    Report Number
    MW5092205
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 9, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LEAKING CATHETER OF SAME LOT NUMBER LEAKING AT CONNECTION SITE. STAFF CHANGED OUT 2 DIFFERENT J-TUBES AS POSSIBLE CAUSE. STAFF ASSESSED AREA OF LEAKING AND NOTICED IT OCCURRING RIGHT AT CONNECTION OF CATHETER HUB. CHANGED CATHETER WITH DIFFERENT LOT RECEIVED FROM CLC, LEAKING CEASED. ONCOLOGY WILL USE ANOTHER GAUGE NEEDLE AS ABLE (IE: 20 GAUGE). STAFF TO USE ANOTHER LOT AS ABLE. STAFF AWARE TO TEST FOR LEAKAGE PRIOR TO STARTING CHEMO IF USING SAME LOT. NO ADVERSE OUTCOME NOTED, NORMAL SALINE WAS BEING ADMINISTERED TO PT. (PREVIOUSLY, INTERNALLY REPORTED ((B)(6) 2019) THE POSSIBILITY OF THE SAME 22G CATHETER LEAKING AT THE HUB IN 5-CASES WITH SAME LOT NUMBER. NO ADVERSE EVENTS.) COULD NOT SOLELY VERIFY IT WAS THE CATHETER (NO PRODUCT SAVED). STAFF ATTEMPTED TO USE SAME LOT #22G CATHETER ON THIS DATE AND WITNESSED LEAKING AT THE HUB OF CATHETER. PRODUCT (LEAKING CATHETER AND J-LOOP PLACED IN BIO-HAZARD BAG) WILL BE GIVEN TO LOGISTICS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47189 BRAUN INTROCAN SAFETY IV CATHETER INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4252519-020 00VL660518
    47190 BRAUN INTROCAN SAFETY IV CATHETER INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4252519-020 00VL660518
    47191 BRAUN INTROCAN SAFETY IV CATHETER INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4252519-020 00VL660518
    47192 BRAUN INTROCAN SAFETY IV CATHETER INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4252519-020 00VL660518
    47193 BRAUN INTROCAN SAFETY IV CATHETER INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4252519-020 00VL660518
    47194 BRAUN INTROCAN SAFETY IV CATHETER INTRODUCER, CATHETER DYB B. BRAUN MEDICAL INC. 4252519-020 00VL660518

    Patients

    Seq Age Sex Outcome Treatment
    1