BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE WASHING STATION OVERFLOWS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE WASHING STATION OVERFLOWS. CUSTOMER CLEANED THE FILTER BUT THE ISSUE PERSISTS.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. COMMON DEVICE NAME AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE WASHING STATION OVERFLOWS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE WASHING STATION OVERFLOWS. CUSTOMER CLEANED THE FILTER BUT THE ISSUE PERSISTS.

Additional Manufacturer Narrative

BDB HAS MONITORED ITS MDR REPORTING, AND AFTER REVIEW, HAS DETERMINED THROUGH VALID DATA THAT: (1) THE RELEVANT MALFUNCTIONS HAVE NOT CAUSED OR CONTRIBUTED TO FURTHER DEATHS OR SERIOUS INJURIES FOR TWO YEARS, AND (2) THE LIKELIHOOD OF ANOTHER DEATH OR SERIOUS INJURY AS A RESULT OF THE RELEVANT MALFUNCTIONS IS REMOTE. ACCORDINGLY, BDB HAS AMENDED ITS MDR REPORTING GUIDELINES TO DISCONTINUE FURTHER PRESUMPTIVE REPORTING OF MALFUNCTIONS ASSOCIATED WITH LIQUID LEAKAGE AND SPLASH COMPLAINTS. MFR. # 2916837-2022-00352 WAS FILED UNDER PREVIOUS GUIDANCE AND IS NOW CORRECTED TO BE A NON-REPORTABLE EVENT. II. THE AFOREMENTIONED AMENDMENT TO THE BDB MDR REPORTING GUIDELINES WAS BASED ON THE FOLLOWING RATIONALE: TO EVALUATE THE IMPACT OF THIS PROPOSED CHANGE, AN ASSESSMENT OF THE COMPLAINT AND ADVERSE EVENT REPORTING HISTORY WAS PERFORMED FOR MALFUNCTIONS ASSOCIATED WITH SERIOUS INJURIES OR DEATHS RELATED TO LIQUID LEAKAGE AND SPLASH EVENTS. THE ASSESSMENT CONFIRMS THERE HAVE BEEN NO REPORTS OF SERIOUS INJURY OR DEATH RELATED TO LIQUID LEAKAGE OR SPLASH EVENTS FOR THE LAST TWO YEARS (SEP. 2020 THRU NOV. 2022). III. WE ALSO NOTE THAT THE LIKELIHOOD OF ANOTHER DEATH OR SERIOUS INJURY AS A RESULT OF THE RELEVANT MALFUNCTIONS IS REMOTE. SPECIFICALLY, A LIQUID LEAKAGE OR SPLASH OF A CHEMICAL OR POTENTIALLY BIOHAZARDOUS FLUID WOULD BE READILY APPARENT TO THE USER AND IS UNLIKELY TO COME IN CONTACT WITH EYES, MOUTH, OTHER MUCOUS MEMBRANE, AND NON-INTACT SKIN, OR CAUSE PARENTERAL CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS. USERS ARE ALSO INSTRUCTED TO FOLLOW UNIVERSAL PRECAUTIONS INCLUDING WEARING PPE PER THE PRODUCTS USER DOCUMENTATION, AND THE REQUIREMENTS IN THE OSHA BLOODBORNE PATHOGEN GUIDELINE. AS SUCH, THE RISK OF SERIOUS INJURY OR DEATH OCCURRING RELATED TO MALFUNCTIONS CAUSING LIQUID LEAKAGE OR SPLASH EVENTS WOULD BE IMPROBABLE.