BD PIPETTE TIPS 1000UL CONDUCTIVE FILTERED

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING SEVERAL BD VIPER LT TIP KITS (CATALOG # 441996, BATCH # 1003624) WITH MISSING CARTON LABELING. BD INVESTIGATION REQUIRED REVIEW OF THE CUSTOMERS SUBMITTED RETURNED PHOTOGRAPHIC EVIDENCE AS WELL AS COMPLAINT TRENDING REVIEW. REVIEW OF THE CUSTOMERS SUBMITTED RETURNED PHOTOGRAPHIC EVIDENCE REVEALS A BD VIPER LT TIP KIT WITH MISSING CARTON LABELING, THUS CONFIRMING THE CUSTOMERS REPORT. REVIEW OF COMPLAINT TRENDING REVEALS THIS TO BE THE FIRST REPORT OVER THE PAST YEAR, WHICH BD IS CONSIDERING TO BE AN ISOLATED INCIDENT AT THIS TIME. IF AN ADDITIONAL RELATED REPORT IS RECEIVED OVER THE NEXT YEAR, BD WILL LAUNCH A TIP SUPPLIER INVESTIGATION. BD WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH BD VIPER LT TIP KITS WITH MISSING CARTON LABELING. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING 15,360 BD PIPETTE TIPS 1000UL CONDUCTIVE FILTERED MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "4 BOXES OF ITEM #441996 WAS FOUND TO MISSING BD ITEM LABEL. "