SWAB ALCOHOL 100 BX 1200 SPAIN

Description of Event or Problem

THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE QUALITY CONTROL DEPARTMENT HAS ANALYZED THE WIPES RECEIVED. DURING THE ANALYZES THEY HAVE DETECTED THAT SOME WIPES DO NOT HAVE ITS LOT NUMBER READABLE. FOR THIS REASON THEY ARE REJECTING THE WIPES. WE ARE ANALYZING THE NEW ENTRY OF BD WIPES WITH ANALYSIS NUMBER. WE STARTED WITH THE TIGHTNESS TESTS IN THE DIFFERENT CONDITIONS THAT WE HAVE BEEN CARRYING OUT AND THEY COMPLY WITH THE TEST. NEXT, WE CONTINUE WITH THE OTHER TESTS AND DETECT THAT THE BATCH NUMBER IS NOT READ ON SEVERAL OF THE SAMPLED WIPES. THIS DID NOT OCCUR IN THE SAMPLE PROVIDED BY BD.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY CUSTOMER RETURNED A PHOTO OF BD ALCOHOL SWABS FROM LOT # 9296216. CUSTOMER STATES THAT SOME WIPES DO NOT HAVE ITS LOT NUMBER READABLE. THE PHOTO WAS EXAMINED AND EXHIBITED AN ILLEGIBLE LOT NUMBER ON SOME OF THE SWAB PACKETS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9296216. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION MAINTENANCE LOGBOOK ENTRY ON (B)(6) 2019 CONFIRMS THE PRINT HEADS WERE CLEANED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS." RATIONALE BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT SWAB ALCOHOL 100 BX 1200 SPAIN WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE QUALITY CONTROL DEPARTMENT HAS ANALYZED THE WIPES RECEIVED. DURING THE ANALYZES THEY HAVE DETECTED THAT SOME WIPES DO NOT HAVE ITS LOT NUMBER READABLE. FOR THIS REASON THEY ARE REJECTING THE WIPES. WE ARE ANALYZING THE NEW ENTRY OF BD WIPES WITH ANALYSIS NUMBER. WE STARTED WITH THE TIGHTNESS TESTS IN THE DIFFERENT CONDITIONS THAT WE HAVE BEEN CARRYING OUT AND THEY COMPLY WITH THE TEST. NEXT, WE CONTINUE WITH THE OTHER TESTS AND DETECT THAT THE BATCH NUMBER IS NOT READ ON SEVERAL OF THE SAMPLED WIPES. THIS DID NOT OCCUR IN THE SAMPLE PROVIDED BY BD.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 6 APRIL 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9296216. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

Additional Manufacturer Narrative

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 SWAB ALCOHOL 100 BX 1200 SPAIN WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE QUALITY CONTROL DEPARTMENT HAS ANALYZED THE WIPES RECEIVED. DURING THE ANALYZES THEY HAVE DETECTED THAT SOME WIPES DO NOT HAVE ITS LOT NUMBER READABLE. FOR THIS REASON THEY ARE REJECTING THE WIPES. WE ARE ANALYZING THE NEW ENTRY OF BD WIPES WITH ANALYSIS NUMBER. WE STARTED WITH THE TIGHTNESS TESTS IN THE DIFFERENT CONDITIONS THAT WE HAVE BEEN CARRYING OUT AND THEY COMPLY WITH THE TEST. NEXT, WE CONTINUE WITH THE OTHER TESTS AND DETECT THAT THE BATCH NUMBER IS NOT READ ON SEVERAL OF THE SAMPLED WIPES. THIS DID NOT OCCUR IN THE SAMPLE PROVIDED BY BD.