BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 20852736 · Received December 5, 2024

    Report

    Report Number
    20852736
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 13, 2024
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    OXQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: SKIN PROTECTANT WIPE IN CENTRAL LINE DRESSING KIT WAS DRY WHEN PACKAGING FOR PROTECTANT WIPE OPENED. BACKGROUND: A SKIN PROTECTANT IS APPLIED TO THE SKIN UNDER THE CENTRAL LINE DRESSING. THE PRODUCT INFOR # IS 161938 "TRAY DRESSING CVAD ADULT". THE PRODUCT NAME ON THE LABEL IS "MEDLINE DRESSING KIT: ADULT CVAD/ARTERIAL LINE (INCLUDING DIALYSIS AND LARGE BORE CATHETERS). MEDLINE PRODUCT #DT18390A, LOT #2024051090, EXPIRATION DATE [REDACTED DATE]. ASSESSMENT: UNKNOWN REASON WHY SKIN PROTECTANT PAD DRIED OUT WHEN IN UNOPENED PACKAGING. RECOMMENDATION: REPORT PLACED TO TRACK AND TREND IF ANY FURTHER DRESSING SETS WITH THE SAME PROBLEM. MANUFACTURER RESPONSE FOR SKIN PROTECTANT WIPE, (BRAND NOT PROVIDED) (PER SITE REPORTER) REPORTED TO MFG REP ON [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049756 MEDLINE DRESSING CHANGE TRAY OXQ MEDLINE INDUSTRIES, INC. DT18390A 2024051090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose