BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C2200 - UNO OR/OP SUCTION

    MDR report key: 11543010 · Received March 22, 2021

    Report

    Report Number
    3007966929-2021-00008
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 1, 2021
    Report Date
    March 2, 2021
    Manufacturer
    UNOMEDICAL ZAVODSKAYA STREET 50
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(6). A BATCH RECORD REVIEW WAS PERFORMED. NO NCR RELATED TO COMPLAINT ISSUE WERE INITIATED FOR COMPLAINT ORDER DURING PRODUCTION. PICTURES WERE RECEIVED AND EVALUATED. THE DEFECT IS ¿LINT / PIECES OF PAPER IN THE PACKAGING THEREBY CONTAMINATING THE OPERATING ROOM¿. DEFECT IS CONFIRMED ON THE BASE OF THE PICTURES. ROOT CAUSE INVESTIGATION WAS PERFORMED VIA EVENT TW1443093 ¿PIECES OF PAPER IN THE PACKAGING OF OP-FLEX¿. ON THE BASE OF THE AVAILABLE INFORMATION THE INVESTIGATION CONCLUDES THAT THE ROOT CAUSE FOR THE ISSUE IS REQUIREMENTS FOR CORRECTLY STOPPING OF THE PACKAGING MACHINE ARE NOT SPECIFIED IN PROCESS INSTRUCTION. FOR ELIMINATION OF THIS ISSUE CAPA TW1447191 WAS INITIATED. NO ADDITIONAL INVESTIGATION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 3007966929.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    MDR 3007966929-2021-00008 / DEVICE 1 OF 1. PROCODE: JOL CONTACT OFFICE ADDRESS: DR. (B)(6). (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PRODUCT DISTRIBUTOR THAT A USER FACILITY REPORTED THAT "LINT / PIECES OF PAPER IN THE PACKAGING, THEREBY CONTAMINATING THE OPERATING ROOM". UPON FURTHER REQUEST FOR INFORMATION IT WAS DESCRIBED THAT THE PRODUCT PACKAGING "THESE ARE FIBERS THAT COME LOOSE WHEN THE PACKAGING IS OPENED AND THE PAPER TEARS IN THE PROCESS". THE PRODUCT WAS NOT USED ON A PATIENT, NO HARM REPORTED. PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE SUBMITTED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445083 L3C2200 - UNO OR/OP SUCTION JOL UNOMEDICAL ZAVODSKAYA STREET 50 33047181 333952

    Patients

    Seq Age Sex Outcome Treatment
    1