THE DEVICE HISTORY RECORD OF THE REPORTED LOT NUMBER WAS REVIEWED, AND NO ABNORMALITIES WERE NOTED. HISTORICAL TRENDING WAS DONE. ONE BOX OF GLOVES WAS RECEIVED AS THE SAMPLE, AND THE WATER TEST WAS DONE. NO ABNORMALITIES WERE FOUND ON THE RETURNED GLOVES. WE ARE UNABLE TO IDENTIFY THE POTENTIAL ROOT CAUSE. SINCE THE REPORTED COMPLAINT OF BLOOD CONTAMINATION IMPLIES THAT A HOLE MAY HAVE DEVELOPED DURING OR AFTER USE, THE PROBABLE CAUSE OF THE HOLE MAY BE DUE TO A DIRTY OR WORN OFF FORMER. THE MANUFACTURER HAS BEEN APPRISED OF THIS COMPLAINT FOR CLOSE MONITORING OF THE MANUFACTURING PROCESS. THE MANUFACTURING TEAM HAS TAKEN ACTION BY CLEANING THE FORMERS AND REMOVING WORN OFF FORMERS. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY TRENDS.
N
Patient 1
(B)(6) IS FILING THIS INITIAL MEDWATCH AS THE IMPORTER. THE COMPLAINT WAS FORWARDED TO THE PLANT FOR INVESTIGATION. THE ACTUAL SAMPLE IS NOT AVAILABLE, HOWEVER THE CUSTOMER STATES THAT THEY CAN PROVIDE REPRESENTATIVE SAMPLES. ONCE THE REPRESENTATIVE SAMPLES ARE RECEIVED, THEY WILL BE FORWARDED TO THE PLANT FOR INVESTIGATION. WHEN THEIR INVESTIGATION IS COMPLETED, A FOLLOW UP MEDWATCH WILL BE FILED.
D
Patient 1
NURSE GOT A PATIENT'S BLOOD ON HER GLOVE. WHEN SHE REMOVED THE GLOVE, THE BLOOD WAS ON HER HAND. THE PATIENT WAS DIAGNOSED WITH A BLOODBORNE INFECTIOUS DISEASE PRIOR TO THIS HOSPITALIZATION. NURSE SOUGHT MEDICAL TREATMENT. A PHYSICIAN INSPECTED HER HAND FOR ANY CUTS/SCRATCHES/OPEN WOUNDS (THERE WERE NONE). BASELINE LABS WERE DRAWN, AND SHE WILL HAVE 3 MONTH AND 6 MONTH TESTING. SHE IS DOING FINE NOW.