MEDEX 4-WAY STOPCOCK EXTENSION SET

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THEY HAD THREE INSTANCES REPORTED OF THE TUBING BREAKING OFF A NON-MODULAR CONNECTION. ONE INSTANCE CAUSED A PATIENT TO LOSE A SIGNIFICANT AMOUNT OF BLOOD FROM THEIR ART LINE. THE EVENT OCCURRED DURING USE ON PATIENT. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

Additional Manufacturer Narrative

TWO PICTURES WERE PROVIDED BY CUSTOMER RELATED TO THE FAILURE MODE REPORTED IN THIS COMPLAINT THAT TUBING BREAKING OFF A NON-MODULAR CONNECTION AND RECEIVED 105 SEALED SAMPLES OF MX43860 LOT 6113680, 6 SEALED SAMPLES OF MX43860 LOT 6095830 AND 9 SEALED SAMPLES OF MX43860 LOT 6082808. DURING LOT HISTORY REVIEW THERE WERE NO DISCREPANCIES OR ANOMALIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT. DURING VISUAL INSPECTION, ALL THE SAMPLES PASSED SINCE NO FAILURES OR ANOMALIES WERE DETECTED DURING THE INSPECTION. THE PICTURES PROVIDED BY CUSTOMER WERE ANALYZED AND IT WAS CONFIRMED THAT TUBE P/N: 105C-06 WAS DETACHED FROM PN: A521T-105G2. THE REPORTED CONDITION WAS CAUSED BY THE TUBE, P/N 105C-06, HAVING AN OUT-OF-SPECIFICATION OUTSIDE DIAMETER, WHICH OCCURRED DURING THE SUPPLIER'S MANUFACTURING PROCESS.