MEDEX EXTENSION SETS SINGLE LINE

Additional Manufacturer Narrative

OTHER, OTHER TEXT: H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVALUATION CODES: UPDATED. ONE (1) USED DECONTAMINATED SAMPLE OUTSIDE ITS ORIGINAL PACKAGE AND FIVE (5) UNUSED SAMPLES INSIDE ITS ORIGINAL POUCH WERE RECEIVED. THE USED SAMPLE FAILED FUNCTIONAL TESTING AND ALL UNUSED SAMPLES PASSED TESTING. THE USED SAMPLE WAS INSPECTED UNDER MICROSCOPE TO DETERMINE THE CAUSE OF THE LEAKAGE WHICH WAS NOTED AS A CRACK. THE CRACK APPEARED IN THE KNIT LINE OF THE MOLDED COMPONENT WHICH IS CONSIDERED THE WEAKEST PORTION OF THE PORT. ALL MANUFACTURING TUBING TAPERS ARE ISO COMPLIANT. TAPER USED BY CUSTOMER CANNOT BE CONFIRMED AS ISO COMPLIANT. A ROOT CAUSE FOR THE CRACK COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. NO ACTION TAKEN AT THIS TIME AS CURRENT CONTROLS ARE ADEQUATE FOR THE COMPLAINT REPORTED BY CUSTOMER.

Additional Manufacturer Narrative

510K IS BLANK DEVICE IS EXEMPT. 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 THE SIX (6) INCH Y EXTENSION WAS LEAKING WHILE IN USE WITH PATIENT. NO INJURY AND NO MEDICAL INTERVENTION WAS REPORTED. THE LINES WERE REPRIMED, AND EXTENSIONS WERE REPLACED. THE EXTENSION SET WAS ALSO NOTED TO BE CRACKED IN SUBSEQUENT NIGHTS.