BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL CLEAR HOLDER, NON-STERILE

    MDR report key: 24918383 · Received April 17, 2026

    Report

    Report Number
    1035907-2026-00045
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Report Date
    April 17, 2026
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    IQG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR PRODUCT#: 26530 INCLUDED THE FOLLOWING: VISUAL COMPARISON OF PRODUCT PACKAGING: THE PHOTO PROVIDED BY THE CUSTOMER WAS EXAMINED THAT DISPLAY THE FOLLOWING: TYPE OF PACKAGING: CLEAR BAG. QTY: (B)(4) PCS. IN A BAG. PRODUCT NUMBER: 26530. PRODUCT DESCRIPTION: MULTI -SAMPLE LUER HOLDER. LOT NUMBER: NO LOT NUMBER PRINTED OR LOT IDENTIFICATION ON THE BAG. THE CURRENT PRODUCT BAG NOW DISPLAYS THE FOLLOWING INFORMATION: TYPE OF PACKAGING: CLEAR BAG. PRODUCT NUMBER: 26530. LOT NUMBER. UDI. QTY: (B)(4) PCS. IN A BAG. BASED ON THE COMPARISON OF THE PHOTOS PROVIDED BY THE COMPLAINANT AND THE CURRENT PACKAGING, THE REPORTED PRODUCT WAS LIKELY FROM AN OLDER BATCH. EXEL ISSUED VENDOR NOTIFICATION CHANGE REPORT, VNC# 220112 ON OCTOBER 21, 2022, FOR PRODUCT#: 26530 ANNOUNCING AN OVERALL DESIGN CHANGE. THE CURRENT VALIDATED HOLDER WILL BE REPLACED WITH TYPE 143 HOLDER WHICH HAS MORE THREAD RINGS TO PROVIDE A BETTER HOLD OR GRIP ON THE NEEDLE. IF THE PRODUCT IN QUESTION WAS MANUFACTURED AND DISTRIBUTED BEFORE THE VNC WAS ISSUED, THIS DESIGN DIFFERENCE COULD CONTRIBUTE TO THE ISSUE. HOWEVER, SINCE THE LOT NUMBER CANNOT BE TRACED, WE ARE UNABLE TO CONFIRM THIS. BASED ON AVAILABLE INFORMATION, THE INVESTIGATION LIKELY INDICATES THAT THE COMPLAINT PERTAINS TO A PRODUCT BATCH MANUFACTURED PRIOR TO THE VALIDATED DESIGN CHANGE (VNC# 220112). DUE TO THE ABSENCE OF A LOT NUMBER, TRACEABILITY CANNOT BE CONFIRMED. (B)(4).

    Description of Event or Problem · 0

    NEEDLE/BLOOD TUBE HOLDER IS FAULTY AND KEPT POPPING OFF. NO PATIENT INJURY NOTED IN THE REPORT. LOT# UNAVAILABLE AND COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430435 EXEL CLEAR HOLDER, NON-STERILE LUER HOLDER IQG EXELINT INTERNATIONAL, CO. UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown