BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 15718546 · Received November 2, 2022

    Report

    Report Number
    1024879-2022-00637
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) CUSTOMER PHOTO WAS RECEIVED FOR REVIEW AND ANALYSIS. BD IS UNABLE TO CONFIRM THE CUSTOMERS REPORTED DEFECT. TUBE WAS EXPIRED PRIOR TO THE AWARENESS, HOWEVER THE FAILURE MODE CANNOT BE CONFIRMED DUE TO THE LIMITED INFORMATION PROVIDED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED EXPIRED TUBES. THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT THEY USED EXPIRED TUBES. SAT OCT 22 14:01:11 UTC 2022 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS. SAT OCT 22 14:00:50 UTC 2022 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS. PAOLA MENDOZA : (B)(6) 2022 19:14:13 (GMT) SUBJECT: EMAIL (B)(6) 2022, 1:55:14 PM. USER: PAOLA MENDOZA. CREATED ON: (B)(6) 2022 18:55:15. CALL ACTIVITY COMMENT: INFORMATION SENT BY E MAIL. ELIZABETH HOOSIER : (B)(6) 2022 14:37:54 (GMT) . REVIEWED, ALL INFO PRESENT. ELIZABETH HOOSIER : (B)(6) 2022 14:37:40 (GMT) NON-COMPLAINT RATIONALE - BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE CONCERN CITED DOES NOT MEET OUR CRITERIA OF A COMPLAINT ¿ REFER TO COMPLAINT DETERMINATION DECISION TREE (B)(4). CATHERINE CHONG : (B)(6) 2022 09:42:43 (GMT) CUSTOMER INQUIRY/PROBLEM: CUSTOMER IS INQUIRING ON PRODUCT STABILITY DATA THAT WOULD SUPPORT THE USE OF THE TUBE 49 DAYS PAST THE EXPIRY DATE. CUSTOMER STATED THAT SAMPLES WERE TAKEN IN BD PART NUMBER 367986 PAST THE EXPIRY DATE. THE LOT IN QUESTION IS 1230964 WITH AN EXPIRY DATE OF 2022-08-31 AND THESE WERE LAST USED YESTERDAY, OCTOBER 18TH. THE EXPIRED TUBES WERE DISCOVERED TODAY, OCTOBER 19TH BUT CUSTOMER CANNOT CONFIRM HOW MANY WERE USED ALTHOUGH THE SITE HAS ONLY EVER RECEIVED 500 EACH OF THIS LOT SO CUSTOMER BELIEVED < 100 COULD HAVE BEEN IMPACTED. STEPS TAKEN WITH CUSTOMER: DOCUMENTED INQUIRY AS REQUEST FOR INFORMATION. OUTCOME/RESOLUTION: PENDING, TRANSFERRED TO TRAINED ASSOCIATE TO CONTACT CUSTOMER. RATIONALE WHY NO COMPLAINT IS REQUIRED: REQUEST FOR INFORMATION ONLY, CUSTOMER IS NOT ALLEGING A DEFECT. CATHERINE CHONG : (B)(6) 2022 09:42:08 (GMT) SUBJECT: EMAIL (B)(6) 2022, 5:19:15 PM. USER: CATHERINE CHONG. CREATED ON: (B)(6) 2022 09:19:15. CALL ACTIVITY COMMENT: NULL. CATHERINE CHONG : (B)(6) 2022 09:35:43 (GMT) CUSTOMER IS INQUIRING ON PRODUCT STABILITY DATA THAT WOULD SUPPORT THE USE OF THE TUBE 49 DAYS PAST THE EXPIRY DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED EXPIRED TUBES. THIS EVENT OCCURRED ONCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THEY USED EXPIRED TUBES." CUSTOMER STATED THAT SAMPLES WERE TAKEN IN BD PART NUMBER 367986 PAST THE EXPIRY DATE. THE LOT IN QUESTION IS 1230964 WITH AN EXPIRY DATE OF 2022-08-31 AND THESE WERE LAST USED YESTERDAY, OCTOBER 18TH. THE EXPIRED TUBES WERE DISCOVERED TODAY, OCTOBER 19TH BUT CUSTOMER CANNOT CONFIRM HOW MANY WERE USED ALTHOUGH THE SITE HAS ONLY EVER RECEIVED 500 EACH OF THIS LOT SO CUSTOMER BELIEVED < 100 COULD HAVE BEEN IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911303 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 1230964 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown