MEDICAL ACTION INDUSTRIES

Additional Manufacturer Narrative

MEDICAL ACTION INDUSTRIES (MAI) RECEIVED A HOSPITAL COMPLAINT OF TEGEDERM WITH 2% CHG WITHIN KIT 73755 ON (B)(6) 2015. MAI DID NOT HAVE ANY REMAINING STOCK OF COMPLAINT LOT 213403 TO EVALUATE AT THAT TIME. THE DEVICE HISTORY RECORD FOR WORK ORDER 213403 DID NOT INDICATE ANY NON-CONFORMANCES DURING PRODUCTION OF THE ASSOCIATED LOT. SUBSEQUENT WORK ORDERS OF THIS SAME KIT, 73755, WERE INSPECTED. THE CORRECT TEGEDERM DRESSING WAS FOUND TO BE PRODUCED IN CURRENT INVENTORY LOTS. THE RAW MATERIAL FOR THIS COMPONENT WAS EVALUATED AND THE CORRECT TEGEDERM DRESSINGS WITHOUT CHG WERE FOUND FOR THE ITEM; THEREFORE, NO OTHER PRODUCT LOTS APPEAR TO BE AFFECTED. THE WORK ORDER 213403 WAS PRODUCED IN OCTOBER 2015 AND INCLUDED (B)(4) CASES OF PRODUCT WHICH WAS SHIPPED TO FOUR DIFFERENT CUSTOMERS. MAI'S INITIAL INVESTIGATION INDICATES THAT THE ERROR OCCURRED DURING THE WORK ORDER PICKING PROCESS; HOWEVER, THIS INVESTIGATION IS STILL IN PROGRESS FOR ADDITIONAL ROOT CAUSE ANALYSIS AND CORRECTIVE/PREVENTIVE ACTION PLAN.

Description of Event or Problem

ON (B)(6) 2015, (B)(6) REPORTED TO MEDICAL ACTION INDUSTRIES (MAI) THAT THEY HAD FOUND TWO TEGEDERM DRESSINGS WITH 2% CHG ON PATIENTS INSIDE KITS MANUFACTURED BY MAI. THE KITS PURCHASED FROM MEDICAL ACTION INDUSTRIES WERE REF:73775, KIT: PICC/CVC SECURE DRES CHG 20/C, LOT: 213403. THIS KIT SHOULD HAVE CONTAINED A TEGEDERM DRESSING WITHOUT CHG GEL. THESE TWO PATIENTS HAD NO ADVERSE REACTION ASSOCIATED WITH THE CHG DRESSING USE. THE HOSPITAL CONFIRMED NO OTHER PATIENT REACTIONS ASSOCIATED WITH THIS KIT USE.