MEDICAL ACTION INDUSTRIES

Additional Manufacturer Narrative

MAI IS THE MANUFACTURER OF KIT 73818B, KIT: CENTRAL LINE DRES 20/CS, WHICH CONTAINS THE COMPLAINT COMPONENT RYMED INVISION NEUTRAL ADVANTAGE TECHNOLOGY VALVE, (B)(4). UPON RECEIPT OF THIS COMPLAINT, MAI CONTACTED RYMED TECHNOLOGIES REGARDING THE CUSTOMER COMPLAINT. MAI WAS INFORMED THAT RYMED HAD JUST INITIATED A VOLUNTARY RECALL ON THIS COMPONENT FOR THREE AFFECTED LOTS. THE APPROPRIATE RECALL LETTER WAS SUPPLIED TO MAI BY RYMED DETAILING THIS PRODUCT RECALL. ALTHOUGH THE REPORTED INCIDENT KIT LOT NUMBER WAS NOT SUPPLIED BY THE CUSTOMER, MAI WAS ABLE TO CONFIRM THAT SOME SHIPMENTS OF MAI CONVENIENCE KIT 73818B SUPPLIED TO THE CUSTOMER DID CONTAIN THE AFFECTED COMPONENT LOT NUMBERS INVOLVED IN THE PRODUCT RECALL. THE CUSTOMER WAS NOTIFIED OF THE RECALL ON THE MAI MANUFACTURED LOTS IMPACTED BY THIS COMPONENT AND THE RECALL OF THESE KITS HAVE BEEN HANDLED IN COMPLIANCE WITH RECALL PROCEDURES. THE CUSTOMER HAS REQUESTED REVISION OF THIS KIT TO REPLACE THE VALVE WITH A DIFFERENT COMPONENT VALVE. MAI IS IN THE PROCESS OF PRODUCTION APPROVAL AND MANUFACTURE OF THE NEW DRESSING KIT PER HOSPITAL SPECIFICATION.

Description of Event or Problem

MEDICATION ACTION INDUSTRIES (MAI), AN OWENS & MINOR COMPANY, IS THE MANUFACTURER OF KIT 73818B, KIT: CENTRAL LINE DRES 20/CS, WHICH CONTAINS THE COMPLAINT COMPONENT RYMED INVISION NEUTRAL ADVANTAGE TECHNOLOGY VALVE, (B)(4). MAI RECEIVED A COMPLAINT REGARDING THE RYMED TECHNOLOGIES VALVE (RYM-5001) BREAKING DOWN WHEN USED FOR CONDUCTION OF A CENTRAL LINE DRESSING CHANGE PROCEDURE AT (B)(6) MEDICAL CENTER ICU UNIT. THE COMPLAINT WAS RECEIVED BY MAI ON 12/31/2015. RYMED TECHNOLOGIES IS THE MANUFACTURER OF THIS AFFECTED COMPONENT, (B)(4), WHICH IS ASSEMBLED INTO AN MAI BRANDED CENTRAL LINE DRESSING KIT 73818B. HOSPITAL HAS CONFIRMED THAT THERE WERE NO PATIENT INJURIES ASSOCIATED WITH THIS COMPLAINT.