BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT:PEDSCONNECTORCHANGE DA 20/CS

    MDR report key: 25055679 · Received May 1, 2026

    Report

    Report Number
    1030451-2026-00010
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 1, 2026
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    OFF
    UDI-DI
    20809160025304
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT, MC100 LOT 14216147 PURCHASED FROM SPECIFICATION DEVELOPER, ESTABLISHMENT: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. (FDA REGISTRATION 9617594). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON APRIL 29, 2026. 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

    MC100 MICROCLAVE VALVE CAPS ARE EXHIBITING CRACKING AND LEAKAGE. ON (B)(6) 2026, THE CUSTOMER PROVIDED ADDITIONAL DETAILS INDICATING THAT THE ISSUE OCCURRED DURING DIRECT PATIENT CARE, INVOLVING MEDICATION AND BLOOD LEAKAGE, WITH AT LEAST ONE AFFECTED PATIENT DEVELOPING A BLOODSTREAM INFECTION. MEDICAL INTERVENTION WAS REQUIRED, INCLUDING CAP REPLACEMENT, ANTIBIOTIC TREATMENT FOR THE INFECTION, AND INCREASED PATIENT MONITORING. NO PROCEDURAL DELAYS WERE REPORTED; THE ACTIVITY BEING PERFORMED AT THE TIME WAS ROUTINE CENTRAL LINE CAP CHANGES UNDER STERILE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623309 KIT:PEDSCONNECTORCHANGE DA 20/CS KIT:PEDSCONNECTORCHANGE DA 20/CS OFF MEDICAL ACTION INDUSTRIES 58360D 329067 20809160025304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other