BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIRRUS BLUE 800

    MDR report key: 21863323 · Received April 18, 2025

    Report

    Report Number
    3015335034-2025-00002
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    January 30, 2024
    Report Date
    March 14, 2025
    Manufacturer
    IDEAL QUALITY SDN BHD
    Product Code
    LZA
    PMA / PMN Number
    K151750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THE REPORTED DETAIL FOR MEDICAL DEVICE REPORT#: MW5167781, THE RELATED PRODUCT WITH CATALOGUE NUMBER#: 10-803B-0 WAS MANUFACTURER BY IDEAL QUALITY SDN BHD, LOCATED AT LOT: 6103, JALAN HAJI ABDUL MANAN / KU8, KAWASAN PERINDUSTRIAN MERU SELATAN, 41050 KLANG, SELANGOR DARUL EHSAN, MALAYSIA. THE RELATED MEDICAL DEVICE WAS SHIPPED UNDER KOSSAN INTERNATIONAL SDN BHD AS FOREIGN EXPORTER. THERE IS A CLERICAL ERROR IN THE EVENT DATE: 30 JAN 2024; BASED ON THE SEQUENCE OF EVENT DESCRIBED AND REPORTED, THE EVENT DATE SHOULD BE 30 JAN 2025. THIS CATALOGUE NUMBER: (10-803B-0) REPORTED IN MAUDE DATABASE (MW 5167781) WAS SUPPLIED TO CUSTOMER IN BLUE COLORED, HOWEVER, THE DEVICE WAS STATED AS BLACK IN THE MAUDE DURING THE INVESTIGATION OF THE COMPLAINT, DEVICE HISTORY RECORD AND RETAINED SAMPLE IS NOT ABLE TO BE RETRIEVED FOR REVIEW DUE TO UNAVAILABILITY OF INFORMATION SUCH AS PO NUMBER AND LOT NUMBER. AFTER REVIEWING THE DETAILS PROVIDED BY THE CUSTOMER, THE PATIENT HAD USED A SIZE LARGE (L) GLOVE INSTEAD OF SIZE EXTRA-LARGE (XL) DUE TO XL ORDER NOT BEING DELIVERED AS EXPECTED. THESE GLOVES ARE DESIGNED AND MANUFACTURED PER ASTM D6319-19 (2023) STANDARD, STANDARD SPECIFICATION FOR NITRILE EXAMINATION GLOVES FOR MEDICAL APPLICATION. THE STANDARD DEFINED THE WIDTH SPECIFICATION FOR EACH SIZE (X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE, XX-LARGE) RESPECTIVELY, FOR SELECTION OF PROPER GLOVE SIZE AS BELOW X-SMALL = 70 +/-10MM, SMALL = 80 +/-10MM, MEDIUM = 95 +/-10MM, LARGE = 110 +/- 10MM, X-LARGE = 120 +/-10MM, XX-LARGE = 130 +/-10MM. AN IMPROPER FIT (NOT DONNING THE PROPER GLOVE SIZE) ESPECIALLY WHEN THE GLOVE IS UNDERSIZE OR TOO SMALL, CAN RESTRICT THE HAND MOVEMENT AND BLOOD CIRCULATION WHICH MAY CAUSE BRUISES DURING USE. BESIDES, CONTINUAL WEARING (OF UNDERSIZE GLOVE) WITH REPETITIVE MOTIONS MIGHT INCREASE THE PRESSURE AND FICTION ON HANDS, RESULTING IN BRUISING.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT'S CAREGIVER CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT ORDER (B)(4) NOT BEING DELIVERED ON (B)(6) AS EXPECTED SHE HAD TO USE LARGE GLOVES INSTEAD OF EXTRA-LARGE GLOVES. THIS CAUSED BRUISING ON HER HANDS. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775113 CIRRUS BLUE 800 NITRILE EXAM GLOVE LARGE, BLUE COLORED LZA IDEAL QUALITY SDN BHD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other