PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ONE PHOTO WAS PROVIDED FOR EVALUATION. VISUAL EVALUATION OF THE PHOTO SHOWED LIDSTOCK PACKAGING FROM THE REPORTED ITEM NUMBER. IT DID NOT CONFIRM ANY DEFECT. THE PROVIDED PICTURE DOES NOT OFFER THE DETAILS NECESSARY TO CONFIRM THE REPORTED DEFECT OR DETERMINE ANY ROOT CAUSE AT THIS TIME. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. 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.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER STATES THAT TWO EPIDURAL CATHETERS HAVE FALLEN APART DURING REMOVAL FROM THE PATIENT. BOTH ARE FROM THE SAME LOT NUMBER. BOTH PATIENTS WERE FEMALE OB PATIENTS.