Description of Event or Problem · 0
I RECEIVED A 3 MONTH SUPPLY OF CURE MEDICAL, LLC'S 14 FR, 16" STRAIGHT TIP, STERILE, INTERMITTENT URINARY CATHETERS WITH FUNNEL END (REORDER NUMBER (B)(4)). THEIR PHONE NUMBER ON THE PACKAGE IS (B)(4). MY SUPPLIER IS (B)(4). THE ORDER CONSISTS OF 9 BOXES (30 PER BOX) FOR TOTAL OF 270 CATHETERS. WHEN I OPENED ONE OF THE BOXES FOR THE FIRST TIME LAST NIGHT ((B)(6) 2021) AND OPENED THE FIRST CATHETER, I NOTICED WHAT APPEARED TO BE CLEAR LIQUID DROPLETS INSIDE THE CATHETER. IN ADDITION, THE OUTSIDE OF THE CATHETER DID NOT APPEAR "POLISHED" BUT SEEMED TO HAVE A RESIDUE ALONG ITS LENGTH. I DO NOT KNOW WHAT THE SUBSTANCE IS. WHEN I TRIED INSERTING A TWIST-TIE INTO THE CATHETER, IT SEEMED LIKE THE DROPLETS WERE POSSIBLY AN OILY SUBSTANCE SINCE IT MOVED IT AROUND BUT DIDN'T SOAK INTO THE TWIST-TIE. I THEN OPENED A DIFFERENT BOX AND LOOKED AT ANOTHER UNOPENED CATHETER THROUGH THE PACKAGING. IT HAS THE SAME DROPLETS INSIDE OF IT AND THE RESIDUE APPEARANCE. I WENT THROUGH ALL 9 BOXES AND ALL OF THE CATHETERS HAVE THE SAME APPEARANCE WITH THE DROPLETS AND APPARENT RESIDUE. THIS IS THE FIRST TIME I HAVE SEEN ANY OF THE CURE MEDICAL CATHETERS WITH ANY DEFECT IN THE FEW YEARS I HAVE USED THEM. NORMALLY, THEY ARE HIGHLY POLISHED AND CLEAR. ALL 9 BOXES ARE FROM LOT 201118-3 WITH AN EXPIRATION DATE OF 10/28/2025. THEY WERE MADE IN (B)(4). I HAVE ATTACHED PHOTOS OF THE UNIT THAT I OPENED. I WILL NOT USE ANY OF THESE CATHETERS DUE TO THE OBVIOUS DEFECTS. I HAVE NOT NOTIFIED ABC MEDICAL YET SINCE THEY ARE CLOSED TODAY FOR THE WEEKEND. I WILL NOTIFY THEM ON MONDAY. PLEASE ADVISE. FDA SAFETY REPORT ID# (B)(4).