ON THEIR 3500A REPORT, THE END USER LISTS THE LOT NUMBER AS #1915 AND THE EXPIRATION DATE AS JUNE 2022. HOWEVER, THAT LOT NUMBER HAS NEVER BEEN USED BY PROTEK, AND AFTER REVIEWING MANUFACTURING RECORDS, IT WAS DETERMINED THAT PROTEK ALSO DOES NOT HAVE AN EXPIRATION DATE OF JUNE 2022 FOR THIS PRODUCT. PROTEK HAS CONTACTED THE END USER AND IS CURRENTLY IN THE PROCESS OF TRYING TO CLARIFY/CONFIRM THESE DETAILS. PROTEK HAS ALSO REQUESTED FOR THE END USER TO PROVIDE A PICTURE OF THE PRODUCT LABELING, AND TO RETURN THE PROBE COVER INVOLVED IN THE EVENT (IF AVAILABLE), TO BE EVALUATED BY PROTEK. MORE INVESTIGATION IS IN PROGRESS AND ADDITIONAL INFORMATION WILL BE PROVIDED TO FDA AS A FOLLOW-UP REPORT, WHEN AVAILABLE. USER FACILITY REPORT # (B)(4).
D
Patient 1
ACCORDING TO THE ORIGINAL REPORTER FROM (B)(6) HOSPITAL, THE SURGICAL TEAM HELD OPEN A STERILE PROBE COVER SO THAT IT COULD BE INSERTED A TRANSTHORACIC ULTRASOUND PROBE. THE PROBE WAS INSERTED AND THE SURGEON BEGAN TO PERFORM AN EPICARDIAL ECHOCARDIOGRAM PROCEDURE. AFTER THE SURGEON STARTED TO USE THE PROBE, HE NOTICED A SMALL HOLE IN THE PROBE COVER, AND THE SALINE LEAKED OUT INTO THE STERILE FIELD. HE PROMPTLY HANDED BACK THE PROBE AND COVER; A NEW COVER WAS THEN USED WITHOUT INCIDENCE.
N
Patient 1
AFTER CONTACTING THE END USER, PROTEK WAS INFORMED THAT THE PRODUCT PACKAGE AND THE COVER USED WERE NO LONGER AVAILABLE TO BE RETURNED OR HAVE PHOTOS TAKEN; THEY WERE DISCARDED AFTER USE. DUE TO NOT HAVING THE PRODUCT OR PACKAGE AVAILABLE FOR EVALUATION AND CONFIRMATION OF THE IDENTIFICATION OF THE PRODUCT, PROTEK CAN ONLY CONCLUDE THAT THE PRODUCT USED BY THE HOSPITAL WAS NOT MANUFACTURED BY PROTEK - PROTEK HAS NO MANUFACTURING RECORDS FOR THE PRODUCT REPORTED (MODEL #1020) WITH THE LOT NUMBER AND EXPIRATION DATE PROVIDED BY THE END USER ON THE ORIGINAL REPORT. NO ACTIONS NEEDED AT THIS TIME.
D
Patient 1
ACCORDING TO THE ORIGINAL REPORTER FROM (B)(6) HOSPITAL, THE SURGICAL TEAM HELD OPEN A STERILE PROBE COVER SO THAT IT COULD BE INSERTED A TRANSTHORACIC ULTRASOUND PROBE. THE PROBE WAS INSERTED AND THE SURGEON BEGAN TO PERFORM AN EPICARDIAL ECHOCARDIOGRAM PROCEDURE. AFTER THE SURGEON STARTED TO USE THE PROBE, HE NOTICED A SMALL HOLE IN THE PROBE COVER, AND THE SALINE LEAKED OUT INTO THE STERILE FIELD. HE PROMPTLY HANDED BACK THE PROBE AND COVER; A NEW COVER WAS THEN USED WITHOUT INCIDENCE.