PORTEX GENERAL ANESTHESIA BAGS

Additional Manufacturer Narrative

A PRODUCT SAMPLE WAS RECEIVED AND IS AWAITING EVALUATION AND 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. UDI NUMBER UNKNOWN, NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE TEAR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE AND THREE (3) PICTURES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND THE CIRCUIT BREATHING PRODUCT WITH A BAG WHICH PRESENTS TEARS AND DAMAGE ON IT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED AS FROM THE MANUFACTURING PROCESS SINCE THE FAILURE REPORTED COULD NOT BE REPRODUCED USING THE TOOLS FROM ASSEMBLY AND PACKAGING PROCESS. THEREFOR THE DAMAGE (BROKEN) WAS AFTER THE PRODUCT LEFT SHM FACILITIES. THIS ISSUE WILL BE MONITORED FOR ANY INCREASE IN OCCURRENCE. IF THE OCCURRENCE OF THIS ISSUE INCREASES SIGNIFICANTLY, ADDITIONAL INVESTIGATIVE ACTION WILL BE TAKEN ACCORDINGLY. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).