PORT DRESSING KIT

Description of Event or Problem

I AM REPORTING A RECURRING PRODUCT QUALITY DEFECT WITH A MEDLINE PORT DRESSING KIT (REORDER #: (B)(4), LOT NUMBER: 26BBN891). THE LEFT EDGE OF THE 16X24 STERILE WRAP MAT WAS NOT FOLDED INWARD STRAIGHT FROM THE FACTORY, LEAVING THE PROTECTIVE ENVELOPE/TORTUOUS FOLD COMPLETELY OPEN. THIS MANUFACTURING ERROR BROKE THE STERILE FIELD BARRIER BEFORE OPENING. BECAUSE OF THIS UNSEALED LEFT EDGE, THE INNER PAPER PACKET CONTAINING THE STERILE GLOVES FELL OUT OF THE PACKAGE ON ONE OCCASION. ADDITIONALLY, BEFORE REALIZING THE FOLD WAS DEFECTIVE, I ACCIDENTALLY GRABBED THE EXPOSED STERILE WRAP, FORCING ME TO SCRAP THE KIT AND RESTART. I CONTACTED (B)(6) PHARMACY TO REPORT PROBLEM AND REQUEST NEW KITS, BUT I RECEIVED A BATCH WITH THE SAME ISSUE AND SAME LOT NUMBER. THE SECOND REPLACEMENT BATCH (LOT # 26CBD615) DOES NOT HAVE THE AFOREMENTIONED FOLD ISSUE--NO FOLD/STERILITY ISSUES HAVE BEEN DETECTED THUS FAR. (B)(6) SAID THEY SHOULD BE STERILE, SO I USED ONE OR TWO VERY CAREFULLY SINCE I WAS OUT OF KITS, BUT I HAVE SINCE STOPPED USING LOT -891 TO AVOID INFECTION RISKS. I HAVE NOT YET HEARD BACK FROM (B)(6), BUT I HAVE FOLLOWED UP.