ADAPTER,UNIVERSAL,CUFF,22MM ID

Additional Manufacturer Narrative

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE ADAPTOR CRACKED DURING USE WHILE THE PATIENT WAS "MOVING". THE CUSTOMER REPORTED THAT AFTER THE INCIDENT OCCURRED THERE WAS A "LARGE LEAK IN SYSTEM" REQUIRING THE ADAPTOR TO BE CHANGED "URGENTLY". THE CUSTOMER REPORTED THAT THE PATIENT IS "STABLE" AND THERE WAS NO MEDICAL TREATMENT REQUIRED. THE CUSTOMER REPORTED DID NOT REPORT ANY SERIOUS INJURY RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO THE CUSTOMER, ON (B)(6) 2025, THE ADAPTOR CRACKED DURING USE WHILE THE PATIENT WAS "MOVING".

Additional Manufacturer Narrative

UPDATED H3: DEVICE EVALUATED BY MANUFACTURER; UPDATED H6: INVESTIGATION FINDINGS (C); UPDATED H6: INVESTIGATION CONCLUSIONS (D).