COMBINED SPINAL & EPIDURAL

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN 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. SAMPLE EVALUATION: NO SAMPLE WERE RETURNED FOR EVALUATION; HOWEVER, WE RECEIVED 2 CUSTOMER PICTURES OF A COMPLAINED ESPOCAN + DS+PST+PENC 0.42X138, 5MM 27G. INVESTIGATION RESULTS: THE FIRST CUSTOMER PICTURE SHOWS THE PACKAGE WITH THE VARIABLE DATA. THE SECOND CUSTOMER PICTURE SHOWS THE CLOSED SOFT TIP CATHETER 20G NON-STERILE WITH A COMPARISON/REFERENCE SAMPLE. AT THE USED CATHETER THE PART WITH THE CATHETER TIP IS CUT OFF. THE CUT OFF PART IS NOT SHOWN. 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 SUCH DAMAGES MAY OCCUR WHEN THE CATHETER WILL BE WITHDRAWN AGAINST THE CANNULA BEVEL AND THEREBY SHEAR OFF. RECOMMENDATION FROM INSTRUCTION FOR USE: NEVER PULL THE CATHETER THROUGH THE NEEDLE AS IT MAY OTHERWISE SHEAR OFF. CONCLUSION: UPON INSPECTION BASED ON THE RECEIVED PICTURE, NO MECHANICAL DAMAGES OR MANUFACTURING FAULTS WERE OBSERVED. THEREFORE, WE ASSUME A FAULT DURING THE APPLICATION PROCESS. THE COMPLAINT IS NOT CONFIRMED.

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "CATHETER BROKE DOWN IN PATIENT BODY."