MEDICAL ACTION INDUSTRIES

Additional Manufacturer Narrative

A REVIEW OF THE HISTORY OF CHANGE REQUESTS FOR CENTRAL LINE DRESSING KITS, 68909, CONFIRMS THERE HAVE BEEN NO COMPONENT CHANGES MADE TO THE KIT SINCE ORIGINAL MANUFACTURING INITIATED IN 2006. AT THE TIME OF COMPLAINT RECEIPT, MAI DID NOT HAVE ANY INVENTORY OF THE COMPLAINT PRODUCT OR COMPONENT LOT AVAILABLE FOR FURTHER INSPECTION. A THREE YEAR COMPLAINT HISTORY FOR THE KIT AND OTHER KITS CONTAINING THIS SAME DRESSING (LOT), SHOWS NO OTHER COMPLAINTS RECEIVED OF SIMILAR NATURE ASSOCIATED WITH REPORT OF PATIENT REACTION. THERE HAVE ADDITIONALLY BEEN NO INTERNAL NON-CONFORMANCES FOR THIS COMPONENT WITHIN THE PAST THREE YEARS. THE DEVICE HISTORY RECORD FOR THE KIT PRODUCTION LOT WAS REVIEWED; ALL IN-PROCESS INSPECTIONS WERE CONDUCTED AND FOUND TO BE CONFORMING. THE TEGADERM COMPONENT WAS DOCUMENTED TO HAVE BEEN PICKED FOR THE WORK ORDER FROM THE CORRECT WAREHOUSE LOCATION FOR THIS COMPONENT. A HISTORY REVIEW OF THE WAREHOUSE LOCATION CONFIRMS NO OTHER SIMILAR DRESSINGS WERE PLACED IN THE SAME LOCATION WHICH WOULD ATTRIBUTE TO AN INCORRECT COMPONENT. THE ROOT CAUSE FOR THIS PATIENT REACTION; THEREFORE, REMAINS UNKNOWN BUT ISOLATED IN NATURE. MEDICAL ACTION INDUSTRIES (MAI) HAS LOGGED THE COMPLAINT INTO OUR TRENDING DATABASE WHERE WE WILL CONTINUE TO MONITOR FOR ANY SUBSEQUENT COMPLAINTS OR TRENDS FOR THIS ISSUE. 3M HAS BEEN NOTIFIED OF THE REPORTED OCCURRENCE.

Description of Event or Problem

OFFICE MANAGER CALLED IN COMPLAINT TO CUSTOMER SERVICE INQUIRING AS TO WHETHER SOMETHING HAD CHANGED WITH DRESSING CONTAINED IN THE CENTRAL LINE DRESSING KIT, 68909, MANUFACTURED BY MEDICAL ACTION INDUSTRIES. A PATIENT HAD A REACTION TO THE DRESSING COMPONENT. ON 02/16/2017, MORE DETAILS WERE RECEIVED FROM THE PHYSICIAN REGARDING THIS OCCURRENCE. THE PATIENT HAD BEEN RECEIVING WEEKLY INFUSIONS SINCE (B)(6) 2017 WITH NO PRIOR REACTIONS. ON (B)(6) 2017, THE PATIENT STARTED HAVING ADVERSE EFFECTS INCLUDING BLISTERING (RASH) AROUND THE DRESSING AREA. THE OFFICE HAS TRIED SEVERAL DIFFERENT SUPPLIES TO TREAT THE SKIN IRRITATION, BUT THE PATIENT IS STILL EXPERIENCING ISSUES. THE PHYSICIAN TREATED THE PATIENT SYMPTOMS AND THE PICC LINE WAS REMOVED. MEDICAL ACTION INDUSTRIES (MAI) MANUFACTURES CONVENIENCE KIT ITEM 68909, CENTRAL LINE DRESSING KIT; HOWEVER, 3M IS THE MANUFACTURER OF THE COMPLAINT COMPONENT TEGADERM DRESSING. THE COMPONENT IS VENDOR PART NUMBER 1655NS (LOT: 202109XO) AND IS A TRANSPARENT TEGADERM POLYURETHANE FILM COATED WITH HYPOALLERGENIC ADHESIVE.