MEDICAL ACTION INDUSTRIES

Additional Manufacturer Narrative

MEDICAL ACTION INDUSTRIES RECEIVED THE ABOVE STATED COMPLAINT FROM (B)(6) ON 08/08/2016. AT THE TIME OF COMPLAINT RECEIPT, MEDICAL ACTION INDUSTRIES OPENED INTERNAL COMPLAINT (B)(4). MEDICAL ACTION INDUSTRIES CONFIRMED WITH THE HOSPITAL THAT THE SORBAVIEW DRESSING, (B)(4), MANUFACTURED BY CENTURION MEDICAL PRODUCTS WHICH WAS INCLUDED AND CHOSEN DURING INITIAL KIT PRODUCTION WAS AN ADHESIVE FREE CENTER DRESSING. MEDICAL ACTION INDUSTRIES CONFIRMED THE DRESSING INCLUDED WITHIN THE COMPLAINT KIT WAS THE CORRECT DRESSING WHICH MET PRODUCT SPECIFICATIONS FOR THE DEVICE. THIS DRESSING WAS APPROVED FOR PICC LINE DRESSING APPLICATION. MEDICAL ACTION INDUSTRIES PRODUCED 3 PRODUCT LOTS USING THE DRESSING. THIS HOSPITAL COMPLAINT WAS THE FIRST RECEIVED FOR THIS ISSUE. THE NEW PRODUCTS TEAM WORKED WITH THE CUSTOMER TO SELECT A DIFFERENT SORBAVIEW DRESSING WHICH HAS THE ADHESIVE CENTER FOR MORE SECUREMENT PROTECTION. THE STERILE DRESSING VERSION OF THIS NEW DRESSING WAS SHIPPED TO THE CUSTOMER DIRECTLY FROM CENTURION FOR USAGE WITH THE KIT IN THE INTERIM. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO CENTURION MEDICAL PRODUCTS ON 08/16/2016 FOR CORRECTIVE/PREVENTIVE ACTION PLAN FOR THIS COMPONENT. THEY ARE CURRENTLY INVESTIGATING THIS COMPLAINT AS RELATED TO THEIR COMPONENT WITH A PROJECTED COMPLETION DAY OF 30 DAYS.

Description of Event or Problem

(B)(6) REPORTED THAT THE SORBAVIEW SECUREMENT DRESSING CONTAINED WITHIN MEDICAL ACTION INDUSTRIES' PICC DRESSING CHANGE CONVENIENCE KIT, 75648, DID NOT APPROPRIATELY SECURE PATIENT'S PICC LINE. THE PATIENT THEREFORE HAD TO BE ADMITTED TO HOSPITAL BECAUSE THE HOMECARE DIVISION DID NOT HAVE ANYONE ON FRIDAY AFTERNOON TO PLACE A NEW PATIENT LINE. THE PATIENT HAD TO HAVE NEW LINE PLACEMENT WITH MEDICATIONS DUE TO MISSED MEDICATION DOSE. THERE WAS NO KNOWN LONG TERM ADVERSE AFFECTS AS A RESULT OF THIS INSTANCE. THE SORBAVIEW DRESSING, ITEM: (B)(4), IS MANUFACTURED BY CENTURION. THIS COMPONENT IS PURCHASED BY MEDICAL ACTION INDUSTRIES AS AN APPROVED COMPONENT FOR THIS CONVENIENCE KIT.