SWABCAP®, 200-CT. BOX

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

Description of Event or Problem

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.