BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWABCAP®, 200-CT. BOX

    MDR report key: 22536630 · Received July 17, 2025

    Report

    Report Number
    1713468-2025-00011
    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 CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RECEIVED, BUT INVESTIGATION HAS NOT BEEN CONCLUDED.

    Description of Event or Problem · 0

    EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SWAB CAP®, 200-CT. BOX WHERE THE REPORTER STATED ONCOLOGY IS SEEING LEAKS OF BLOOD WHEN CAP ENGAGES WITH THE BD MAXPLUS NEEDLE FREE CONNECTOR. THEY STATED THAT IT IS LIKE IT ACTIVATED IT AND/OR SPONGE PUSHES THE INTERNAL PIECE DOWN. THERE WAS UNKNOWN PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839310 SWABCAP®, 200-CT. BOX CAP, DEVICE DISINFECTANT INTRAVASCULAR ADMINISTRATION SET. QBP ICU MEDICAL, INC. 14234151 00887709079168

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BD MAXPLUS NEEDLE FREE CONNECTOR.