PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

Additional Manufacturer Narrative

H6 - EVALUATION CODES: UPDATED. DEVICE EVALUATION: THE INVESTIGATION OF THE COMPLAINT WAS LIMITED BECAUSE NO SAMPLE WAS RETURNED. CUSTOMER IS CLAIMING THAT THE VALIDITY PERIOD ON THE PACKAGING IS DIFFERENT THAN PERIOD OF TIME IN THE PRODUCT INSTRUCTIONS. THE INSTRUCTION FOR USE MOST RECENT REVISION WAS CHECKED. THERE IS MENTIONED MAXIMUM RECOMMENDED PERIOD OF USE EQUAL TO 48 HOURS. THIS INFORMATION IS NOT RELATED TO THE EXPIRATION DATE. THE EXPIRATION DATE IS DETERMINED BY THE STERILE NYLON SUTURE NO 0 (3.5) WHICH IS DEFINED IN THE MANUFACTURE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. NO FINDINGS WERE OBSERVED. THERE WAS THE CORRECT EXPIRY DATE USED, ACCORDING TO THE SUTURE. UNFORTUNATELY WITHOUT THE SAMPLE OR MORE INFORMATION WE ARE UNABLE TO DETERMINE TRUE ROOT CAUSE OF THIS ISSUE. NO TREND OF CONFIRMED COMPLAINTS IN RELATION WITH THIS ISSUE WAS IDENTIFIED.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN INSPECTION, "IT WAS FOUND THAT THE VALIDITY PERIOD ON THE PACKAGING OF THE EMERGENCY CRICOTHYROIDOTOMY KIT WAS INCONSISTENT WITH THE LIMITED PERIOD OF TIME IN THE PRODUCT INSTRUCTIONS, THUS THE COMPLIANCE OF THE PRODUCT WAS DOUBTFUL." THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

Additional Manufacturer Narrative

D5: OPERATOR OF DEVICE, E1: FIRST AND LAST NAME IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.