MEDEX 3-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER (B)(4). THE DATE OF THAT SUBMISSION WAS 2/7/2025. RECEIVED TWO (2) USED LIST# MX43660, THREE-WAY STOPCOCK AND ONE (1) USED PARTIAL LIST# MX43660, THREE-WAY STOPCOCK. AS RECEIVED, THE EXTENSION TUBING WAS SEPARATED FROM THE STOPCOCK UNIT. THE THIRD STOPCOCK WAS NOT RETURNED, ONLY THE EXTENSION TUBING. NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. AFTER FURTHER INVESTIGATION, THE TUBING END OF ONE SAMPLE WAS OBSERVED TO HAVE DAMAGED SOLVENT. THE COMPLAINT OF SEPARATION CAN BE CONFIRMED BUT NOT REPLICATED. THE COMPLAINT OF LEAKAGE CAN BE CONFIRMED BUT NOT REPLICATED. THE PROBABLE CAUSE IS DUE TO IMPROPER SOLVENT ADHESION AT THE JUNCTION. SEPARATION COULD NOT BE ATTRIBUTABLE TO MANUFACTURING, MOST PROBABLY CAUSED COULD BE RELATED WRONG HANDLING OF THE PRODUCT DURING ITS USE. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.