SWABCAP®, 200-CT. BOX
Received Jul 17, 2025 · Event occurred Jun 1, 2025
Report 1713468-2025-00012 · MDR key 22536870
Device
Generic name
Cap, Device Disinfectant, Intravascular Administration Set.
Manufacturer
Icu Medical, Inc.Catalog number
SCXT3-2000
Lot number
14234151
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
THE DEVICE IS REPORTED NOT AVAILABLE FOR RETURN, HOWEVER, A LOT REVIEW SHOULD BE COMPLETED.
Description of Event or Problem
EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A SWABCAP®, 200-CT. BOX WHERE THE REPORTER STATED THAT ONCOLOGY IS SEEING LEAKS OF CHEMO WHEN CAP ENGAGES WITH THE BD MAXPLUS NEEDLE FREE CONNECTOR. STATED THAT IT IS LIKE IT ACTIVATED AND/OR SPONGE PUSHES THE INTERNAL PIECE DOWN. THERE WAS UNKNOWN PATIENT HARM AS A RESULT OF THIS EVENT.