L3C2200 - UNO OR/OP SUCTION

Additional Manufacturer Narrative

DEVICE 1 OF 1. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. A BATCH RECORD REVIEW WAS PERFORMED. NO NON-CONFORMANCE REPORT (NCR) RELATED TO COMPLAINT ISSUE WERE INITIATED FOR COMPLAINT ORDER DURING PRODUCTION. NO SAMPLES WERE RECEIVED. PICTURE IS RECEIVED AND EVALUATED. THERE IS A HAIR IN A STERILE PACKAGING. DEFECT IS CONFIRMED. ROOT CAUSE INVESTIGATION WAS PERFORMED FOR ¿PRODUCT WITH HAIR INTO PACKAGE¿. ON A BASE OF THE AVAILABLE INFORMATION THE INVESTIGATION REVEALS: THE POSSIBLE CAUSES FOR THE ISSUE ARE: NONCOMPLIANCE WITH THE RULES OF MOVEMENTS AND STAY IN CLASSIFIED ROOMS BY OPERATORS DURING MANUFACTURING PROCESS; CAP DOES NOT PROVIDE FULL COVER OF HAIRS. THE CONTRIBUTING CAUSE FOR THE ISSUE IS: OPERATOR MISTAKE DURING OPERATIONAL CONTROL OF PACKAGING. THIS IS A NOT ISOLATED CASE BUT BASED ON DISTRIBUTION OF COMPLAINTS BY PRODUCTION DATE THERE IS STABLE DECREASE OF COMPLAINTS IN COMPARISON WITH PREVIOUS YEAR. NO CORRECTIVE ACTIONS ARE RECOMMENDED TO IMPLEMENT. RETRAINING OF PRODUCTION OPERATORS ON C906800 AND C805007 WITHIN ANNUAL TRAINING WAS PERFORMED. COMPLAINTS WITH THE ISSUE WILL BE MONITORED. NO ADDITIONAL INVESTIGATION IS NEEDED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT "A HAIR INSIDE THE STERILE PACKAGING". IT IS UNKNOWN IF THE PRODUCT WAS USED, NO HARM REPORTED. A PHOTOGRAPH DEPICTING THE REPORTED COMPLAINT ISSUE WAS SUBMITTED BY THE COMPLAINANT.