ESPOCAN®

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEFECT CANNOT BE CONFIRMED DUE TO NOT HAVING ANY EVIDENCE TO SUPPORT THE REPORTED INCIDENT. RETAINED UNITS WERE EVALUATED AND PASSED THE INTERNAL TESTING. SINCE A SAMPLE WAS NOT RETURNED FOR EVALUATION, THE EXACT ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NONCONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. 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: CONTAMINATED PARTICLE NOTED EITHER IN THE STERILE LOSS OF RESISTANCE SYRINGE OR ONE OF THE DRUGS PULLED UP BY THE DOCTOR INTO THE SYRINGE. THE DRUG WAS TAKEN OUT OF THE COMBINED SPINAL AND EPIDURAL ANESTHESIA TRAY.