PERIFIX®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER: (B)(4). NO SAMPLE AND/OR LOT NUMBER WERE PROVIDED. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A SAMPLE AND/OR LOT NUMBER. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS 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 MEDWATCH MW5166611: DESCRIBE EVENT OR PROBLEM: WHEN GOING TO REMOVE THE EPIDURAL CATHETER, THE RN NOTICED THAT THE EPIDURAL CATHETER WAS DISCONNECTED. HOWEVER, THE TUBING HAD BROKEN OFF OF THE CLAMP. IT WAS DISCONNECTED BY ANOTHER RN. THE PATIENT HAD STATED THAT HER EPIDURAL WAS WEARING OFF AND SHE COULD FEEL "ALMOST EVERYTHING" WHILE SHE WAS PUSHING. STAFF DISPOSED OF THE PRODUCT INSTEAD OF HOLDING FOR REVIEW / INVESTIGATION. NO CUSTOMER INFORMATION PROVIDED.