BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE

    MDR report key: 12134062 · Received July 8, 2021

    Report

    Report Number
    12134062
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    May 7, 2021
    Report Date
    July 2, 2021
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIRST WEEK OF (B)(6) SITUATION: NON-INTACT ENCORE LATEX MOISTURIZING STERILE SURGICAL GLOVES ONLY SIZE (LOT 2003432604). BACKGROUND: HOLES WERE FOUND BETWEEN THE THUMB AND INDEX FINGER WHEN DONNING THESE GLOVES FOR STERILE PROCEDURES IN THE EP LAB. THIS OCCURRED WITH 5 PAIRS OF GLOVES TOTAL, 3 PAIRS IN ONE SINGLE DAY. ALL EVENTS OCCUR WHEN STAFF HAD ALREADY DONNED INTACT UNDER GLOVES. HOLES WERE ALWAYS FOUND IMMEDIATELY AND REPLACED WITH INTACT STERILE GLOVES BEFORE ANY DIRECT PATIENT CARE TOOK PLACE. ASSESSMENT: ALL ENCORE LATEX MOISTURIZING STERILE SURGICAL GLOVES ONLY SIZE 7 ½ (LOT 2003432604) WERE REMOVED FROM THE DEPARTMENT. SECOND WEEK OF MAY SITUATION: NON-INTACT ANSELL ENCORE LATEX MOISTURIZING STERILE SURGICAL GLOVES SIZE 7 (NOT 7 ½ AS PRIOR SBAR) (LOT 2003432604 142-65004). BACKGROUND: AGAIN HOLE FOUND BETWEEN THE THUMB AND INDEX FINGER WHEN DONNING THESE GLOVES FOR STERILE PROCEDURE IN THE EP LAB. THIS OCCURRED WITH 1 PAIRS OF GLOVES. HOLE FOUND IMMEDIATELY AND REPLACED WITH INTACT STERILE GLOVES BEFORE ANY DIRECT PATIENT CARE TOOK PLACE. ASSESSMENT: ALL DEPARTMENT STAFF NOTIFIED AND INSTRUCTED TO CAREFULLY CHECK GLOVE INTEGRITY AFTER DONNING. ESPECIALLY THIS SIZE GLOVE AND LOT#. RL SOLUTION PLACED. MANUFACTURER RESPONSE FOR SURGICAL GLOVES, ANSELL GLOVES SIZE 7 AND 7.5 (PER SITE REPORTER): WE PULLED THE LOT #'S AFFECTED. PRODUCT 2018675 WITH LOT 2003432604; PRODUCT 20687280 WITH LOT 2002042905. ANSELL REPLACED AFFECTED PRODUCT AND SENT A CLOSURE LETTER OF THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036497 ENCORE POLYMER PATIENT EXAMINATION GLOVE LZA ANSELL HEALTHCARE PRODUCTS LLC 2018675 2003432604

    Patients

    Seq Age Sex Outcome Treatment
    1