BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHALTONI IR PACK (SRUTB)619

    MDR report key: 11639507 · Received April 9, 2021

    Report

    Report Number
    1423537-2021-00622
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 9, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OIO
    UDI-DI
    10888439526622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOR LOT# 20191112-23-SH REVEALED THE PRODUCT WAS FINISHED ON NOVEMBER 15TH, 2019. NO EXCEPTION WAS RECORDED IN THE DEVICE HISTORY RECORD THAT COULD LEAD TO THE REPORTED INCIDENT. THE AVERAGE LINTING DATA IS 0.150G / 10 PIECES. NO SAMPLE WAS AVAILABLE AT THE TIME OF THE INVESTIGATION. ACCORDING TO THE SUPPLIER, OPERATING ROOM TOWEL IS MADE OF COTTON, SO COTTON FIBER IS BORN. THE SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (B)(4). IN THE FOLDING PROCESS, SUPPLIER USED ONE CLOTH PAD UNDER 100PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. RESULTS OF THE INVESTIGATION REVEALED NO ABNORMAL SITUATION OCCURRED IN PRODUCTION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS SHARED WITH THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ACTION TAKEN AT THIS TIME, BUT THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SURGICAL TOWEL PWTB04-STM, INCLUDED IN THIS KIT SAN44SRUTB ARE LEAVES FRAGMENTS ON THE WIRES AND CATHETERS DURING ARTERIOGRAM PROCEDURE. NO INJURY OR ADVERSE EFFECT REPORTED. NO PATIENT DEMOGRAPHICS WERE PROVIDED UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537854 SHALTONI IR PACK (SRUTB)619 RADIOGRAPHIC CONTRAST TRAY OIO MEX03 MEXICO-JUAREZ PRESOURCE SAN44SRUTB 375878 10888439526622

    Patients

    Seq Age Sex Outcome Treatment
    1