PRESSURE MONITORING SET

Additional Manufacturer Narrative

FOLLOW UP IS ON GOING TO CLARIFY WHETHER THE DEVICE IS AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION RESULTS. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

Description of Event or Problem

AS REPORTED, THIS PRESSURE MONITORING SET TUBING WAS EXCESSIVELY STIFF, WHICH LED TO THE TUBING LUER LOCKS DISCONNECTING ON THEIR OWN. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION G1 (CONTACT OFFICE TELEPHONE NUMBER) AND H6 (INVESTIGATION FINDINGS / INVESTIGATION CONCLUSIONS). PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. NO PRODUCT WAS RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE PRODUCT, IT IS UNABLE TO PERFORM A COMPLETE INVESTIGATION OF THE REPORTED EVENT. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. THERE ARE INTERNAL CONTROLS DURING THE MANUFACTURING PROCESS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION.