BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR PACK (LUUNB)625

    MDR report key: 9513310 · Received December 23, 2019

    Report

    Report Number
    1423537-2019-00387
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    December 3, 2019
    Report Date
    February 11, 2020
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    LRO
    UDI-DI
    10888439302288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FORTY PIECES OF SAMPLES WERE RETURNED FOR INVESTIGATION. THE SUCTION TEST WAS CONDUCTED ON THE RETURNED SAMPLES. NO OBVIOUS ABNORMAL SITUATION WAS FOUND ON THE SAMPLES. OR TOWELS ARE MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. WE ARE CONTINUOUSLY WORKING TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED THE FOLLOWING: 1. SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. 2. THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. 3. LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10 PIECES). 4. IN THE FOLDING PROCESS, THE SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER. THE COMPLAINT INFORMATION WAS INFORMED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. THERE IS NO ACTION TAKEN AT THIS TIME, HOWEVER, WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. AT THIS TIME THE SAMPLES HAVE NOT BEEN RECEIVED AT THE PLANT, THEREFORE THE SAMPLES HAVE NOT BEEN EVALUATED AS OF THIS TIME. OPERATING ROOM TOWELS ARE MADE OF COTTON, SO LINT IS BORN AND INEVITABLE. THE SUPPLIER IS CONTINUOUSLY WORKING WITH CARDINAL HEALTH TO BETTER CONTROL THE LINTING AND HAVE IMPLEMENTED SEVERAL MEASURES TO IMPROVE IT: 1) SUCTIONS MACHINES HAVE BEEN INSTALLED IN GREY CLOTH ROLLING PROCESS, DYEING PROCESS AND CUTTING PROCESS. 2) THE SUCTION PROCESS WAS ADDED BEFORE PRODUCT'S FINAL FOLDING, AND WORKERS DO IT ACCORDING TO STANDARD OPERATION PROCEDURE REQUIREMENT. 3) LINTING TEST METHOD AND ACCEPTABLE CRITERIA WAS STIPULATED TO SEE THE SUCTION RESULTS. (=0.38G/10 PIECES). 4) IN THE FOLDING PROCESS, THE SUPPLIER USED ONE CLOTH PAD UNDER 100 PIECES SEMI-FINISHED PRODUCTS TO AVOID LINTING STUCK ONTO THE PRODUCTS DURING PRODUCT'S TRANSFER.

    Description of Event or Problem · 1

    BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE BLUE OR TOWELS ARE REPORTEDLY LINTING. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308930 LUMBAR PACK (LUUNB)625 GENERAL SURGERY TRAY (KIT) LRO MEX03 MEXICO-JUAREZ PRESOURCE SOP41LUUNC UNKNOWN 10888439302288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other