BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I.V. START KIT

    MDR report key: 21967173 · Received May 6, 2025

    Report

    Report Number
    1030451-2025-00003
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    March 3, 2025
    Report Date
    June 26, 2025
    Manufacturer
    MEDICAL ACTION INDUSTRIES, INC.
    Product Code
    LRS
    UDI-DI
    20809160004965
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THIS EVENT IS NOT AVAILABLE FOR EVALUATION. THE COMPLAINT COMPONENT PART NUMBER (B)(4) (TRANSPORE TAPE) IS MANUFACTURED BY NANJING 3H MEDICAL PRODUCTS CO., LTD. (FDA REGISTRATION 3007607706). A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE COMPONENT MANUFACTURER. 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.

    Additional Manufacturer Narrative · 0

    SUPPLIER PERFORMED TEST ON THE RETENTION SAMPLE WHICH CONFIRMED PRODUCT ADHESION MET SPECIFICATION REQUIREMENT. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE WERE NO NONCONFORMANCES DURING PRODUCTION OF THE COMPLAINT LOT. MEDICAL ACTION INDUSTRIES IS THE CONVENIENCE KIT MANUFACTURER; EACH PRODUCTION LOT IS INSPECTED TO ENSURE CORRECT TAPE HAS BEEN ALLOCATED PER THE BILL OF MATERIALS. NO PROCESSES PERFORMED DURING KNITTING WOULD CONTRIBUTE TO THIS COMPLAINT. A TWELVE-MONTH REVIEW SHOWS FOUR PAST COMPLAINTS WITH THREE DIFFERENT ISSUES, ONE FOR THIS SAME ISSUE OF NOT STICKING FOR A DIFFERENT TAPE LOT. THIS PRODUCT LOT SHIPPED TO VARIOUS CUSTOMERS WITH NO ADDITIONAL REPORTS FOR ISSUE ON THE COMPLAINT LOT. SUPPLIER FEEDBACK INDICATES CUSTOMERS SHOULD WAIT FOR THE SKIN TO COMPLETELY DRY AFTER USING ALCOHOL AND CHLORHEXIDINE FOR DISINFECTION BEFORE APPLYING THE TAPE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE 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

    CUSTOMER STATES TRANSPORE TAPE DID NOT ADHERE TO THE PATIENT'S SKIN, CAUSING BLEEDING, CATHETER MIGRATION, AND ASSOCIATED COMPLICATIONS. THE CATHETER WAS NOT SECURED ENTIRELY, SITE HAD TO DIVERT TO A NONSTERILE TAPE TO RESOLVE, AND THERE WAS SOME BLEEDING INDICATIVE OF IRRITATION OR CATHETER ISSUE PER CUSTOMER INCIDENT DETAILS. THE ISSUE WAS RESOLVED BY USING A CARTRIDGE TRANSPORT CONTAINER WHICH CAUSED MILD CONTAMINATION. ON (B)(6) 2025, THE CUSTOMER STATED THE ADHESIVE TAPE DOESN¿T HAVE AS GOOD ADHESION AS OTHER KITS PURCHASED BEFORE, THEREFORE, IT IS DIFFICULT TO HAVE A PROPER FITTING OR SECURING OF THE IV CATHETER. AS A SOLUTION, THE MEDICAL TREATMENT WAS TO USE ANOTHER IV KIT. THE DELAY IN PROCEDURE WAS APPROXIMATELY 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98241 I.V. START KIT I.V. START KIT LRS MEDICAL ACTION INDUSTRIES, INC. 267004 324996 20809160004965

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other