SWABCAP®, 200-CT. BOX
Received Jul 17, 2025 · Event occurred Jun 1, 2025
Report 1713468-2025-00011 · MDR key 22536630
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. 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
DEVICE HAS BEEN RECEIVED, BUT INVESTIGATION HAS NOT BEEN CONCLUDED.
Description of Event or Problem
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.