BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV KIT 100 CS

    MDR report key: 23976536 · Received January 6, 2026

    Report

    Report Number
    1030451-2026-00002
    Event Type
    Injury
    Date Received
    January 6, 2026
    Report Date
    February 18, 2026
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    LRS
    UDI-DI
    20809160019341
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS PROVIDED BY THE CUSTOMER FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT IDENTIFIED NO NONCONFORMANCES DURING PRODUCTION. TRENDING ANALYSIS INDICATES THAT THIS EVENT IS ISOLATED. A SCAR WAS ISSUED TO THE SUPPLIER (INNOVATE MEDICAL LLC) TO FURTHER INVESTIGATE AND ADDRESS THE MATTER. PROBABLE ROOT CAUSES: THE TOURNIQUET USED IN THE PHLEBOTOMY KIT WAS CHANGED FROM A SOFTER BLUE MATERIAL TO A ¾-INCH WHITE TOURNIQUET WITH A MORE RIGID, TEXTURED SURFACE. THE ¾-INCH TOURNIQUET IS MORE PRONE TO ROLLING AND PINCHING DURING USE COMPARED TO THE STANDARD 1-INCH VERSION. THE WHITE TOURNIQUET REQUIRES A HIGHER CONCENTRATION OF PIGMENT TO MASK THE NATURAL STRAW-COLORED RUBBER COMPOUND, RESULTING IN A NOTICEABLY HARDER SURFACE COMPARED TO BLUE OR ORANGE TOURNIQUETS. PATIENTS WITH FRIABLE OR SENSITIVE SKIN ARE AT INCREASED RISK OF ABRASION OR SKIN TEARING DURING TOURNIQUET APPLICATION. IN ACCORDANCE WITH STANDARD NURSING PRACTICE, APPLICATION TECHNIQUES SHOULD BE ADJUSTED WHEN USING FIRMER TOURNIQUETS ON PATIENTS WITH DELICATE SKIN. INNOVATE MEDICAL LLC (TOURNIQUET MANUFACTURER) WILL DISCONTINUE THE WHITE TOURNIQUET DUE TO ITS LIMITED USE IN HOSPITAL SETTINGS. IN ADDITION, STANDARDIZED SURFACE SOFTNESS AND FRICTION SPECIFICATIONS WILL BE APPLIED ACROSS ALL TOURNIQUET PRODUCTS TO BETTER MEET MARKET EXPECTATIONS AND REDUCE RISK. TRAINING WILL ALSO BE PROVIDED TO PRODUCT DEVELOPMENT, QUALITY, AND SALES TEAMS TO INCREASE AWARENESS OF THE HEIGHTENED POTENTIAL FOR SKIN INJURY IN GERIATRIC PATIENTS AND INDIVIDUALS WITH SENSITIVE SKIN. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    INCIDENT TWO - THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE IV START CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT, R6384, LOT 2110001, PURCHASED FROM SPECIFICATION DEVELOPER AND REPACKAGE/RELABELLER INNOVATE MEDICAL, LLC. (FDA REGISTRATION 2321034). THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THE CURRENT TOURNIQUET MATERIAL IS SIGNIFICANTLY ROUGHER THAN THE PREVIOUS BLUE VERSION AND HAS CAUSED SKIN DAMAGE IN PATIENTS WITH FRAGILE OR HIGHLY SENSITIVE SKIN, INCLUDING TEARING. HISTORICALLY, TOURNIQUETS WERE MADE OF A BLUE, SOFTER MATERIAL; HOWEVER, THE NEW WHITE TOURNIQUETS ARE NOTICEABLY ROUGHER AND LESS SUITABLE FOR PATIENTS WITH DELICATE SKIN. THE OTHER CONCERN WAS THAT IT WAS WHITE AND COULD EASILY BLEND INTO THE BED LINEN, WHICH IS ALSO CONCERNING SINCE IT IS LESS NOTICEABLE AND COULD MORE EASILY BE UNINTENTIONALLY LEFT ON THE PATIENT. THE REPORTER INDICATED THEY DON¿T HAVE DETAILS AROUND A SPECIFIC INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32677 IV KIT 100 CS IV KIT 100 CS LRS MEDICAL ACTION INDUSTRIES 73969B 337299 20809160019341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other