CLEAR SEQUENCE CENTRAL LINE DRESSING CHANGE

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CLEAR SEQUENCE CENTRAL LINE DRESSING CHANGE KIT CONTAINING MEDICHOICE BRANDED SKIN PREP COMPONENT (R6384), LOT 2408JK510A. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem

PATIENT HAD A REACTION (DESCRIBED AS A BURN) FOLLOWING USE OF MEDICHOICE SKIN PREP COMPONENT INCLUDED IN MEDICAL ACTION INDUSTRIES CLEAR SEQUENCE CENTRAL LINE DRESSING CHANGE KIT. THE SITE MONITORED SKIN FOR ANY INFECTION SIGNS DURING HEALING, NO FURTHER TREATMENT OR DETAILS WERE PROVIDED BY THE COMPLAINT REPORTER.

Additional Manufacturer Narrative

NO SAMPLES AVAILABLE; THE PHOTOGRAPH CONFIRMS THE REACTION TO THE R6384 COMPONENT. THE SUPPLIER (B)(4) REVIEWED CLEANING AND MAINTENANCE RECORDS OF THE EQUIPMENT USED IN THE PRODUCTION OF THIS LOT. THE CLEANING AND MAINTENANCE WERE CARRIED OUT AS REQUIRED. PER SUPPLIER, THE CHEMICAL RAW MATERIALS AND PACKAGING MATERIALS USED IN THE SKIN PREP ARE SOURCED FROM QUALIFIED SUPPLIERS AND WERE ALL SUBJECTED TO SAMPLE INSPECTIONS BEFORE STORAGE. VISUAL AND MICROBIAL INSPECTIONS PASSED. THE SUPPLIER TESTED R6384 (LOT 2410JK510A) WITH CHLORAPREP PRODUCT BY CONDUCTING A HUMAN SKIN PATCH TEST. AFTER APPLYING CHLORAPREP PER IFU, R6384 WAS PLACED ON THE SKIN FOR 48 HOURS. NO ADVERSE REACTION OCCURRED. THE SUPPLIER PROVIDED RECORDS OF SKIN IRRITATION TESTING CONDUCTED BY A QUALIFIED THIRD-PARTY TEST LAB ON PRODUCT. THE RESULTS INDICATE THE RESPONSE AREA OF SKIN TESTED DID NOT EXCEED THE CONTROL. THERE WAS NEGLIGIBLE RESPONSE. THE ROOT CAUSE OF COMPLAINT REMAINS UNKNOWN. A COMPLAINT TRENDING ANALYSIS CONFIRMS NO POSITIVE TREND FOR THIS ISSUE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.