COMBINED SPINAL & EPIDURAL

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR AND NO ABNORMALITY WAS OBSERVED DURING IN-PROCESS INSPECTION. INVESTIGATION STATEMENT: WE RECEIVED ONE USED ACCU-BLOC-KATH.20G, EINZ. UNST."S-O"SOFT-T OUT OF ONE ESPOCAN + DS+PST+PENC 0.42X138,5MM 27G IN OPEN PACKAGING. AT THE USED ACCU BLOC CATHETER THE PART WITH THE CATHETER TIP IS CUT OFF THE CUT OFF AREA SHOWS A SMOOTH STRUCTURE. THE CUT OFF PART WAS NOT HANDED OVER BY THE CUSTOMER. THE DAMAGED AREA AT THE CATHETER IS SLANTED AND IS DUE TO THE RETRACTION OF THE CATHETER IN THE CANNULA. SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. THE CATHETERS WERE TAKEN TO A 100% EXAMINATION AND THEREFORE NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS ARE ALLOWED. BECAUSE OF THIS WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS. RECOMMENDATION NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF. THEREFORE, THE COMPLAINT IS NOT CONFIRMED.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

Description of Event or Problem

ACCORDING EVENT DESCRIPTION: CATHETER SNAPPED DURING INSERTION OF EPIDURAL CATHETER PROCEDURE.