BD FACSFLOW¿ SHEATH FLUID

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131. G.1 - REPORTING OFFICE CONTACT - FAHMY RAZAK. G.1 - MANUFACTURING SITE CONTACT - FAHMY RAZAK. H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE PRODUCT WITH INCORRECT GTIN NUMBER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: PHOTO PROVIDED BY BD DISTRIBUTOR SHOWS THAT INCORRECT GTIN NUMBER BHR PART 342003 LOT 2322809810 WAS REVIEWED WAS REVIEWED. THE MATERIALS MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POSSIBLE CAUSE IS RELATED TO SUPPLIER LABELING SYSTEM UPGRADE AND GTIN NUMBER WAS CHANGED WITHOUT GOING THROUGH PROPER NOTIFICATION. BD REGULATORY HAS REVIEWED THE SITUATION AND APPROVED. CORRECTIVE ACTION WAS INITIATED TO ADDRESS THE INCORRECT GTIN NUMBER. BD FOLLOWED UP WITH THE CUSTOMER AND NO RESPONSE WAS RECEIVED REGARDING THE RESOLUTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. REGULATORY, TOGETHER WITH QUALITY, HAVE ADVISED TO ¿USE AS IS¿ AS THERE IS NO IMPACT ON THE PERFORMANCE OR THE SAFETY OF THE PATIENT (RISK IS NEGLIGIBLE) UNTIL THE INVENTORY IS DEPLETED, ALLOWING THE PRODUCT TO BE DISTRIBUTED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT BD FACSFLOW¿ SHEATH FLUID HAD INCORRECT INFORMATION ON LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTRIBUTOR HAVE CHECKED ACTUAL LABEL THEY HAVE IN THE STORAGE FOR BD FACSFLOW PRODUCT 342003 AND THEY HAVE INFORMED ME THAT THEY HAVE PRODUCT WITH INCORRECT GTIN - 59077400243326.

Additional Manufacturer Narrative

IN THIS MDR, BD BIOSCIENCE HEADQUARTERS IN SAN JOSE, CA HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS AVANTOR IS AN OEM MANUFACTURING SITE. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD FACSFLOW¿ SHEATH FLUID HAD INCORRECT INFORMATION ON LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:DISTRIBUTOR HAVE CHECKED ACTUAL LABEL THEY HAVE IN THE STORAGE FOR BD FACSFLOW PRODUCT 342003 AND THEY HAVE INFORMED ME THAT THEY HAVE PRODUCT WITH INCORRECT GTIN - (B)(4).