MEDEXSTANDARD BORE EXTENSION SET WITH MALE LUER LO

Description of Event or Problem

IT WAS REPORTED THAT THE ITEM IS NOT WORKING CORRECTLY, BLOOD KEEPS LEAKING OUT; THERE IS NO STOPPING MECHANISM. NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. TWO BOXES OF MX452FL WITH (B)(4) EACH BOX WERE RECEIVED. ALL (B)(4) OF MX452FL WERE RECEIVED UNOPENED. THE SAMPLES DESCRIBED ON THE COMPLAINT WERE NOT RECEIVED. TEN UNITS, FIVE FROM EACH BOX, WERE TESTED PER INTERNAL PROCEDURES. THE TESTS PERFORMED WERE PULL TEST, AIR TEST, AND LEAK TEST. ALL UNITS PASSED ALL TESTS PER SPECIFICATION. UNABLE TO REPRODUCE THE FAULT LISTED ON THE COMPLAINT DESCRIPTION. NO FAULT FOUND WITH THE DEVICE. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. REVIEW OF DHR SHOWS THERE WERE NO NON-CONFORMANCES WRITTEN DURING THE MANUFACTURING OF THE DEVICE.