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 LOT(S) 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 REPORT STATED THAT SOME OF THE LUER LOCKS DO NOT APPEAR TO HAVE A FIXED STOPPING POINT- LIKE THEY HAVE BEEN STRIPPED OUT. THE REPORT STATED THAT AS A RESULT THE INFUSION SETS WOULD THEN COME OFF OF THE MANIFOLD DURING THE PROCEDURES, CAUSING A DELAY IN THE PROCEDURE WHILE THE ISSUE WAS REMEDIED. THE COMPLAINANT REPORTED THAT OUT OF (B)(4) EACHES IN A BOX OF THE PRODUCT THEY HAVE HAD ISSUES WITH AT LEAST (B)(4) OF THE DEVICES. A COMPLAINT SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT.