BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWABCAP®, 200-CT. BOX

    MDR report key: 22535274 · Received July 17, 2025

    Report

    Report Number
    1713468-2025-00010
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 1, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    QBP
    UDI-DI
    00887709079168
    PMA / PMN Number
    K130975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY TWO (2) NEW UNITS. LIST #SCXT3-2000, SWABCAP®, 200-CT. BOX, ONE (1) NEW, MAXPLUS CLEAR NEEDLELESS CONNECTOR. ONE (1) USED UNKNOWN, GRIPPER CONNECTED WITH TWO (2) USED, MAXPLUS CLEAR NEEDLELESS CONNECTOR AND ONE (1) USED, 0.9% SODIUM CHLORIDE INJECTION, USP NORMAL SALINE SYRINGE WERE RETURNED FOR EVALUATION. AS RECEIVED, A SMALL TEAR ON THE TOP OF ONE OF THE USED MAXPLUS CLEAR NEEDLELESS WAS OBSERVED. THE BRAND NEW SWABCAPS WERE OPENED AND VISUALLY INSPECTED, NO ANOMALIES OR ISSUES WERE IDENTIFIED, THE RETURNED MAXPLUS CLEAR NEEDLELESS CONNECTOR WAS TESTED, WHEN THE SEAL SURFACE WAS BARELY TOUCHED A LEAK FROM THE MAXPLUS WITH THE TEAR COME OUT. COMPLAINT OF LEAKS CANNOT BE CONFIRMED, SINCE LEAK WAS CONFIRMED EVEN WHEN SWABCAP WAS NOT PRESENT. THE PROBABLE CAUSE CANNOT BE DETERMINED SINCE THIS IS A NON-ICU MEDICAL CONNECTOR. THE LOT HISTORY WAS REVIEWED; NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE USED DEVICE IS NOT AVAILABLE FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD IS PENDING.

    Description of Event or Problem · 0

    THE ISSUE OCCURRED ON AN UNSPECIFIED DATE IN THE ONCOLOGY UNIT AND INVOLVED A SWABCAP®, 200-CT. BOX THAT REPORTEDLY LEAKED SALINE WHEN THE ENGAGES WITH THE BD MAXPLUS NEEDLE FREE CONNECTOR DURING PATIENT USE. IT APPEARED ACTIVATED AND/OR THE SPONGE PUSHED THE INTERNAL PIECE DOWN. THERE WAS NO REPORT OF ANY HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764648 SWABCAP®, 200-CT. BOX CAP, DEVICE DISINFECTANT QBP ICU MEDICAL, INC. 14234151 00887709079168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MAXPLUS NEEDLE FREE CONNECTOR, MFR BD.| SALINE, MFR UNK.