SWAB ALCOHOL 100 BX 1200
Received Jul 30, 2020 · Event occurred Jul 20, 2020
Report 1920898-2020-00943 · MDR key 10347478
Device
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) USA HAS BEEN USED AS A DEFAULT. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL B INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR MISSING LABEL INFORMATION (EXPIRATION DATE) DUE TO UNKNOWN LOT NUMBER. A REVIEW OF RISK MANAGEMENT DOCUMENT 151RMN-0001-01 REVISION 01 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (DEVICE FAMILY, REPORTED DEFECT) WAS NOT CAPTURED ON THIS DOCUMENT. PLEASE REFER TO ATTACHED MEMO FOR QUALITY ENGINEERING ASSESSMENT. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED 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. UNABLE TO PERFORM A DHR REVIEW FOR MISSING LABEL INFORMATION (EXPIRATION DATE) DUE TO UNKNOWN LOT NUMBER. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. 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: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 THE SWAB ALCOHOL 100 BX 1200 EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE RECEIVED FOR INTAKE: 20-JUL-2020. MATERIAL NO. 326895 BATCH NO. UNKNOWN (PROVIDED: 0096400). VERBATIM: CONSUMER REQUESTED EXPIRATION DATE ON ALCOHOL SWABS, STATED THAT THERE IS NO EXPIRATION DATE ON THE BOX.