AMBU AURAGAIN SIZE 4

Description of Event or Problem

TRAUMATIC INJURY WITH MASK REMOVAL. DURING SEVERAL USES OF THE MASK, THE PATIENT HAD INJURIES WITH BLEEDING WHEN THE MASK WAS REMOVED. ONE PATIENT HAD A CUT ON THE TONGUE FRENULUM AND A HEMATOMA, WHICH REQUIRED AN ENT CHECK. THE MASK WAS USED CORRECTLY BY TRAINED MEDICAL STAFF. THE ISSUE HAS BEEN REPORTED TO QUALITY FOR FOLLOW-UP AND ANALYSIS. PATIENT OUTCOME: UNKNOWN.

Additional Manufacturer Narrative

THIS COMPLAINT HAS BEEN RE-EVALUATED AS PART OF A CORRECTIVE ACTION RELATED TO AN OBSERVATION ON RISK MANAGEMENT IDENTIFIED DURING AN FDA INSPECTION. H6 - HEATH EFFECT CODE: NO CODE AVAILABLE FOR "CUT ON THE TONGUE FRENULUM". INVESTIGATION: NEITHER SAMPLE NOR PICTURES ARE AVAILABLE FOR INVESTIGATION, VISUAL INSPECTION IS NOT PERFORMED. ACCORDING TO THE CUSTOMER REPORT, THE PATIENT HAD INJURIES WITH BLEEDING WHEN THE LARYNGEAL MASK WAS REMOVED. THE MEDICAL ADVISOR'S ASSESSMENT IS AS FOLLOWS: "LINGUAL FRENULUM TEARS ARE A KNOWN COMPLICATION ASSOCIATED WITH SUPRAGLOTTIC AIRWAY (SGA) DEVICES, TYPICALLY OCCURRING DURING THE INSERTION PHASE. THIS USUALLY HAPPENS WHEN THE TONGUE OBSTRUCTS THE PATHWAY AND FORCEFUL ADVANCEMENT DISPLACES THE TONGUE POSTERIORLY, LEADING TO FRENULUM INJURY. IN SUCH CASES, THE CLINICIAN WOULD GENERALLY FEEL RESISTANCE DURING INSERTION AND APPLY ADDITIONAL FORCE." ACCORDING TO THE IFU "DO NOT USE EXCESSIVE FORCE WHEN INSERTING AND REMOVING AURAGAIN AS THIS CAN LEAD TO TISSUE TRAUMA." ADDITIONALLY, IF THE PRODUCT HAS SHARP EDGES, THIS COULD CAUSE THROAT FISSURES DURING INSERTION. REGARDING PRODUCT APPEARANCE, FLASH/BURS ARE REQUIRED WITH NO SHARP EDGES, AS SPECIFIED IN THE AMBU INJECTION CONTROL PROCEDURE. A 100% APPEARANCE INSPECTION DURING PRODUCTION PROCESS WITH AMBU WORK INSTRUCTION. AFTER REVIEWING THE COMPLAINTS DURING THE PAST ONE YEAR, THERE HAVE BEEN NO COMPLAINTS TRACKING PRODUCT APPEARANCE ISSUES TO PATIENT INJURY OR BLEEDING. IN THIS CASE, NO SAMPLE WAS RETURNED, THE ROOT CAUSE CANNOT BE DETERMINED. SEVERAL ATTEMPTS HAVE BEEN MADE TO REACH OUT TO THE CUSTOMER TO DETERMINE PATIENT CONDITION, WITH NO ADDITIONAL INFORMATION PROVIDED. THE PATIENTS CONDITION REMAINS UNKNOWN. ACCORDING TO THE IFU, ANY APPEARANCE FAILURE SHOULD BE DETECTABLE DURING THE PRE-CHECK, AND "ALWAYS HAVE A SPARE AMBU AURAGAIN READY FOR USE". THE POTENTIAL ADVERSE EVENT BY USING LARYNGEAL MASK HAS BEEN STATED IN IFU. BASED ON THE ABOVE, NO FURTHER CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.