BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM

Additional Manufacturer Narrative

INVESTIGATION ON GOING. SHOULD RELEVANT ADDITIONAL INFORMATION INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THE COMPLAINANT REPORTED THAT THE STRYKER INSTRUMENT SET USED DURING THE PROCEDURE WERE STERILIZED USING AN AESCULAP AG STERILIZATION CONTAINER. ALTHOUGH SURFACE STAINING OF THE CONTAINER WAS NOTED, THE USER DID NOT ASSERT THAT THE DEVICE FAILED TO ACHIEVE PROPER STERILIZATION. DESPITE THE LACK OF EVIDENCE SUGGESTING A CAUSAL RELATIONSHIP BETWEEN THE PATIENT INFECTION AND THE STERILIZATION CONTAINER, B. BRAUN WILL FILE A MEDICAL DEVICE REPORT IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803 OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

IT WAS REPORTED TO AESCULAP INC. THAT A BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM (PART # JK742) WAS USED TO STERILIZE DEVICES FOR A PROCEDURE ON AN UNSPECIFIED DATE. ACCORDING TO THE COMPLAINANT THERE IS STAINING BUILD UP IN THE BOTTOM OF THE STERILE CONTAINERS. THESE CONTAINERS ARE ORDERED AND USED FOR POWER SETS. REPORTEDLY THE CUSTOMER DISCOVERED THE PATIENT INCIDENT WAS FROM BIOBURDEN THEY DISCOVERED AFTER THE CASE ON SET INSTRUMENTS. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AT THIS TIME. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE: (B)(4).