PERIFIX®

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION FX CATHETER BROKE WHILE REMOVING FROM PATIENT. 12 CM OF THE CATHETER REMAINS IN PATIENT AT THIS TIME.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). SECTION D: RECORD REVIEW RELATED DSMS/NON-CONFORMANCE RECORDS IDENTIFIED: [X] NO NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.