DESIGN OPTIONS®

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 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. NOTE: THE ORIGINAL INITIAL MDR FOR THIS CASE WAS INADVERTENTLY SUBMITTED VIA THE "TEST" ACCOUNT OF THE FDA ELECTRONIC SUBMISSION GATEWAY (ESG) WEBTRADER. AS THE ORIGINAL SUBMISSION WAS NOT SUBMITTED THROUGH THE "PRODUCTION" ACCOUNT OF THE FDA ESG WEBTRADER, A NEW INITIAL MDR SUBMISSION IS REQUIRED PER ZOOM CALL WITH SAMEER PHANASE OF THE FDA ESG HELP DESK.

Description of Event or Problem

AS REPORTED BY USER FACILITY, IDENTICAL ISSUES AT WEXFORD. WE HAVE ALSO HAD MANY ISSUES WITH INJECTING THROUGH THE CATHETER AFTER PLACEMENT. FACILITY CONTACT WHO REPORTED THAT DURING OB CASES THE TEST DOSE CAN NOT BE DELIVERED AND THAT SOME OF THE CATHETERS ARE SHEARING. SHE REPORTED THAT THE SAME OUTCOME WAS REQUIRED AS NO BROKEN PIECES FELL OFF IN THE PATIENT BUT A NEW KIT WAS NEEDED AND A NEW CATHETER NEEDED TO BE PLACED.