B.BRAUN

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT.   REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES 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.

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

Description of Event or Problem

PER MEDWATCH NUMBER: (B)(4). EVENT DESCRIPTION: 5CC PLASTIC SYRINGE WAS FOUND TO CONTAIN WHAT APPEARED TO BE A BLACK PARTICLE OF STOPPER. THE PRESENCE OF THIS PARTICLE WAS OBSERVED BY PHYSICIAN PRIOR TO ADMINISTRATION, WHEN TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION WAS DRAWN INTO 5CC PLASTIC SYRINGE. NO INJURY REPORTED.