Q2 8.5 INCH DOUBLE T-SITE IV EXTENSION SET

Additional Manufacturer Narrative

QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem

THE DISTRIBUTOR REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WHEN USING THE IV ADMINISTRATION EXTENSION SET. THE REPORT STATED THAT A 20CC LUER LOCK SYRINGE FULL OF BLOOD WAS ATTACHED TO ONE OF THE DEVICE PORTS, AND UPON INJECTION INTO THE PORT BLOOD SQUIRTED OUT OF ANOTHER PORT. THE REPORT STATED THE DEVICE WAS DISCARDED AND ANOTHER MANIFOLD WAS USED. THE PATIENT WAS 5 MONTHS OLD AND THE IV LINE WAS ATTACHED TO AN INTERNAL JUGULAR CENTRAL LINE. THE COMPLAINANT STATED THERE WAS NO HARM CAUSED TO THE PATIENT BUT THAT THE ISSUE HAD OCCURREC IN THREE DIFFERENT PROCEDURES. THE COMPLAINANT CHOSE TO RETURN SEVEN OF THE UNUSED DEVICE TO THE DISTRIBUTOR FOR ANALYSIS BY THE MANUFACTURER.

Additional Manufacturer Narrative

THE COMPLAINANT RETURNED ONE DEVICE SAMPLE OUT OF THE PACKAGE AND SIX OTHER DEVICES (SAME LOT) STILL SEALED IN THEIR PACKAGES. THE ONE DEVICE SAMPLE APPEARED TO HAVE NOT BEEN USED. VISUAL EXAMINATION OF THE DEVICE FOUND NO ANOMALIES. ALL SEVEN SAMPLES WERE PRIMED WTIH WATER USING A 20 CC SYRINGE, TO SIMILATE THE CONDITIONS STATED BY THE USER. NONE OF THE SAMPLES LEAKED OR SQUIRTED WATER FROM THE PORT PER THE COMPLAINT. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.