DESIGN OPTIONS®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 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.

Description of Event or Problem

AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION FX CATHETERS SHEARING AND KINKING. DETAILED INQUIRY DESCRIPTION TEST DOSE CAN'T BE DELIVERED FOR 552176 AND SOME CATHETERS SHEARING. 1. WERE ANY PIECES OF THE BROKEN CATHETER RETAINED IN THE PATIENT? NO 2. WAS IMAGING REQUIRED? NO 3. WHAT TYPE OF MEDICAL INTERVENTION(S) WERE REQUIRED? NEW CATHETER/KIT WAS USED 4. ARE YOU ABLE TO PROVIDE THE PATIENT GROUP THAT THE DEVICES WERE BEING ADMINISTERED TO (OB, ORTHO, OR OTHER TYPE OF PATIENT)? OB 5. WHAT WAS THE OUTCOME AND PATIENT STATUS? NEW CATHETER PLACED THE ISSUE AT FORBES WAS NOT PLACING THE CATHETER (INSERTION WAS EASY), BUT RATHER BEING UNABLE TO INJECT THROUGH THE CATHETER ONCE PLACED. ADDITIONALLY, THERE HAS BEEN A CATHETER THAT DISCONNECTED DUE TO EITHER BEING BROKEN R DETACHED AT THE ALLIGATOR CLIP.