Q2 CHECKMATE EXTENSION SET

Additional Manufacturer Narrative

VISUAL EXAMINATION OF THE COMPLAINT SAMPLE FOUND THAT THE TUBING FROM THE CHECKMATE COMPONENT APPEARS TO HAVE BEEN REMOVED AND RE-CONFIGURED BY THE CUSTOMER. THE CAP ON THE CHECKMATE ROTATED AS IF IT DID NOT HAVE ANY THREADS. FURTHER EXAMINATION FOUND THAT THE THREADS APPEARED DISTORTED EITHER FROM OVER-TIGHTENING OR BY REPEATED THREADING ONTO OTHER PORTS. IT IS LIKELY THE LUER ON NON-QUEST TUBING COULD HAVE DISTORTED THE HUB THREADING. THE DEVICE HISTORY RECORD FOR THE LOT AND SUBCOMPONENT LOTS WERE REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION.

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 HOSPITAL REPORTED AN ISSUE ENCOUNTERED WITH THE INTRAVENOUS ADMINISTRATION EXTENSION SET DURING USE. THE NURSE STATED THAT SHE WAS UNABLE TO TIGHTEN THE LUER CONNECTION WHERE THE TUBING AND THE MANIFOLD MEET. SHE SAID THAT IT CONTINUES TO SPIN AS IF STRIPPED, AND AS A RESULT IT CAN DISCONNECT DURING USE. FOLLOW UP WITH THE COMPLAINANT FOUND THAT THIS HAD BEEN A SPORADIC ISSUE FOR ABOUT A MONTH, UNTIL THEY BEGAN HEARING FROM THE ANESTHESIA PROVIDERS AND THE RECOVERY ROOM RNS THAT THE IV'S WERE "PULLING APART", ESPECIALLY AFTER TRANSFER/MOVEMENT OF PATIENTS. THE ADDITIONAL INFORMATION REPORTED THAT ON A COUPLE OCCASIONS, IV'S WERE ASSEMBLED IN ANTICIPATION OF BEING USED, AND PLACED ON AN IV POLE TO AWAIT THE PATIENT'S ARRIVAL. IT WAS DISCOVERED THAT THE IV HAD DISCONNECTED (AT THE MANIFOLD SITE DESCRIBED ABOVE) AND THE TUBING WAS ON THE FLOOR. NO ADDITIONAL SPECIFIC INFORMATION OTHER THAN THAT PROVIDED IS AVAILABLE. A DEVICE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE.