BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A (ACD-A), USP, 30 ML

    MDR report key: 2589120 · Received May 25, 2012

    Report

    Report Number
    0001216032-2012-00001
    Event Type
    Injury
    Date Received
    May 25, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    CITRA LABS, LLC
    Product Code
    LYZ
    PMA / PMN Number
    PBK070026
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE; MDR NUMBER: 1825034-2012-00683.

    Description of Event or Problem · 1

    A FEMALE TECHNICIAN WAS DRAWING UP (WITH A SYRINGE) TO PUT 3ML'S OF ACD-A, 30ML SOLUTION IN PREPARATION BEFORE A PATIENT ENTERED THE ROOM AND AIR WAS IN THE SYRINGE. AS THE TECHNICIAN TRIED TO REMOVE THE AIR, THE SOLUTION DISCHARGED IN AN "ARC" MOTION INTO HER EYES, MAINLY HER RIGHT EYE. SHE WEARS CONTACTS. LOCATION OF EVENT: HOSPITAL OPERATING ROOM. PATIENT REACTION/IMMEDIATE CARE: EYES WERE RED AND SHE EXPERIENCED IRRITATION BURNING/ITCHINESS. THE HELP NURSE IMMEDIATELY FLUSHED THE TECHNICIAN'S EYES WITH WATER FOR 10 - 12 MINUTES; HOWEVER, EYES WERE STILL RED. THE TECHNICIAN WENT TO THE ER TO SEEK FURTHER EVALUATION AND THE PHYSICIAN FROM THE ER FLUSHED HER EYES WITH WATER AGAIN FOR 5 MINUTES. THE TECHNICIAN'S EYE IRRITATION WENT AWAY AND THE REDNESS LASTED UNTIL THE NEXT DAY, (B)(6) 2012. THE PHYSICIAN ADVISED THE TECHNICIAN NOT TO WEAR HER CONTACTS FOR THE NEXT 24 HOURS AND DISCHARGED HER BACK TO FULL DUTY. THIS IS A COMPONENT IN A BIOMET KIT. ITEM: 800-0505A, DESCRIPTION: GPS LLL MINI KIT W/30ML ACD-A, DEVICE CODE: KSS, LOT# 112904.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A (ACD-A), USP, 30 ML N/A LYZ CITRA LABS, LLC N/A D19H

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention