BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVACUATED CONTAINER, 1000 ML

    MDR report key: 13087274 · Received December 27, 2021

    Report

    Report Number
    13087274
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    December 9, 2021
    Report Date
    December 21, 2021
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WE HAD TWO 1000 ML VACUUM BODY FLUID BOTTLES ARRIVE FROM (B)(6) WITH A GASH IN THE RUBBER STOPPER RATHER THAN A PINHOLE, THE FIRST CAUSED A HUGE MESS WITH PERITONEAL FLUID ALL OVER WHEN HANDLING, THE SECOND FLUID THAT ARRIVED WE DID LOOK AT THE STOPPER BEFORE HANDLING AND HAD TO FIGURE OUT HOW TO GET THE FLUID OUT WITHOUT A POSSIBLE EXPOSURE/MESS. I HAVE ALREADY NOTIFIED THE (B)(6) NURSE AND (B)(6) DIRECTOR OF THIS ISSUE, THEY ARE ALSO LOOKING INTO THIS IMMEDIATELY AND COMMUNICATING WITH THEIR STAFF. THE TWO LOT NUMBERS ARE: LOT #G152334 EXP. 09/30/2022 AND LOT #G150552 EXP. MANUFACTURER RESPONSE FOR EVACUATED CONTAINER, BAXTER (PER SITE REPORTER): TOOK REPORT TO EVALUTE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987057 EVACUATED CONTAINER, 1000 ML APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY BAXTER INTERNATIONAL INC. 1A8504 G152334 & G150552

    Patients

    Seq Age Sex Outcome Treatment
    1 24090 DA Male