BD ACCURI¿

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD ACCURI¿ THERE WAS A WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A DISCONNECTED TUBING CAUSED WASTE LEAKAGE. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE LINE. IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE? NO. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? NO. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

Additional Manufacturer Narrative

THE EVENT DESCRIBED OCCURRED ON AN RUO INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

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. # 2916837-2023-00059 WAS FILED UNDER PREVIOUS GUIDANCE AND IS NOW CORRECTED TO BE A NON-REPORTABLE EVENT. 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). 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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD ACCURI¿ THERE WAS A WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A DISCONNECTED TUBING CAUSED WASTE LEAKAGE. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE LINE. IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE? NO. WHAT IS THE SOURCE OF LEAK; WASTE LINE OR NON-WASTE LINE? WASTE LINE. IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? NO. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY BASED ON THE EVALUATION IT WAS DETERMINED THAT NO FURTHER INVESTIGATION IS REQUIRED. DCHU HAS REVIEWED THE COMPLAINT AND NO ADVERSE EVENT HAS OCCURRED AT THIS TIME. THIS COMPLAINT MODE WILL BE TRENDED, AND FURTHER INVESTIGATION WILL BE REQUIRED IF AN ACTIONABLE LEVEL IS DETERMINED DURING QUARTERLY POST MARKET SURVEILLANCE (PMS) REVIEW. H3 OTHER TEXT : SEE H.10

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD ACCURI¿ THERE WAS A WASTE LEAKAGE WITHOUT BLEACH NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A DISCONNECTED TUBING CAUSED WASTE LEAKAGE. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES WHAT WAS THE FLUID THAT LEAKED? WASTE LINE IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE? NO WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? NO WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO