BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE SINGLE BASIN GENERAL SURGERY TRAY BLUE DISPOSABLE TOWEL

    MDR report key: 8050544 · Received November 8, 2018

    Report

    Report Number
    8050544
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 1, 2018
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LRO
    UDI-DI
    10887488644226
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MD REGARDING SIGNIFICANT CONCERNS REGARDING LINT/THREAD/DEBRIS SHEDDING FROM THE NEW BLUE STERILE TOWELS. THE NEW BLUE TOWELS LEAVE A LOT OF DEBRIS. THIS IS A SIGNIFICANT STROKE/EMBOLIC RISK DURING NEURO ENDOVASCULAR PROCEDURES. WE HAVE SINCE TESTED THE FOLLOWING CARDINAL ITEMS: TWO PACKS OF DISPOSABLE TOWELS WITH DIFFERENT LOT NUMBERS 180525-16-SH/180322-16-SH (CAT# 28700-004, BAR CODE: ((B)(4)). BLUE DISPOSABLE TOWEL FROM SINGLE BASIN CUSTOM PACK LOT # 963391( CAT # SUT13SBMGA, BAR CODE: ((B)(4)). BLUE DISPOSABLE TOWEL FROM MAJOR BASIN CUSTOM PACK LOT # 980587 (CAT # SUT13BMMGA BAR CODE: ((B)(4)). WITH AND WITHOUT AGITATION. SOAKING IN STERILE SALINE. SOAKING IN STERILE WATER . WE FOUND LINT/DEBRIS IN EVERY TEST, THE MOST SIGNIFICANT AMOUNT OF DEBRIS WE WERE ABLE TO VISUALIZE WAS IN THE TOWEL THAT WAS SOAKING. THE CARDINAL REPS WERE IN HOUSE AND WE NOTIFIED THEM AND SENT THEM THE TEST RESULTS FOR INTERNAL QA REVIEW. TESTED ANOTHER MANUFACTURER GREEN RF OR TOWELS. AGAIN TESTED WITH AND WITHOUT AGITATION, DRY AND THEN SOAKING IN STERILE SALINE. DEBRIS WAS PRESENT , APPEARED LESS THAN THE ABOVE CARDINAL ITEMS. MANUFACTURER RESPONSE FOR GENERAL SURGERY TRAY, CARDINAL HEALTH (PER SITE REPORTER). EMAIL FROM @CARDINALHEALTH.COM. SUBJECT: RE: LINTING WITH OR TOWELS. "..... WE HAVE SUBMITTED A PRODUCT QUALITY REPORT AND HAVE MARKED URGENT SO THAT IT IS PRIORITIZED. I AM ALSO WORKING TO PUT TOGETHER A FEW ALTERNATIVE OPTIONS FOR YOU TO TRY. MORE TO COME ASAP......".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891711 STERILE SINGLE BASIN GENERAL SURGERY TRAY BLUE DISPOSABLE TOWEL GENERAL SURGERY TRAY LRO CARDINAL HEALTH 200, LLC SUT13SBMGA 963391 10887488644226

    Patients

    Seq Age Sex Outcome Treatment
    1 13505 DA