BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE CUSTOM STERILE SURGICAL PACKS

    MDR report key: 19942084 · Received August 7, 2024

    Report

    Report Number
    MW5158223
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    August 1, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE INSTANCES OF CONTAMINANTS FOUND INSIDE STERILE SURGICAL PACKS FROM VENDOR (MEDLINE). ITEMS WERE NOT USED FOR SURGERY, BUT CARE WAS IMPACTED. ON (B)(6) 2024: A HAIR WAS FOUND INSIDE A STERILE SURGICAL PACK AND COMPROMISED THE STERILE FIELD. SURGERY WAS CANCELED BASED ON THE RISK OF INFECTION INTRODUCED BY THIS NON-STERILE ITEM. NEUROSURGERY CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844531 MEDLINE CUSTOM STERILE SURGICAL PACKS GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other