BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST BLOOD COLLECTION TUBE

    MDR report key: 13170870 · Received January 5, 2022

    Report

    Report Number
    3006948883-2021-01046
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 8, 2021
    Report Date
    February 7, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1018233. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2021-02-01. MEDICAL DEVICE LOT #: 1025373. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2021-02-01. MEDICAL DEVICE LOT #: 1082985. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2021-04-01. 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

    THE FOLLOWING FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROFILE: IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST BLOOD COLLECTION TUBE THERE WAS OIL GEL GLOBULES AND DISCOLORED/ABNORMAL ADDITIVE FORM. THIS EVENT WAS REPORTED TO HAVE AFFECTED 7002 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE TUBE WAS FOUND TO HAVE AN ADDITIVE ABNORMALITY ISSUE." ADDITIONAL INFORMATION 12/10/21: THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: "THE YELLOW TUBE BLOCKED THE BIOCHEMICAL ANALYZER CAUSING AN ALAR. FLOATING OIL CAUSE." H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO OIL GEL GLOBULES OR ADDITIVE ABNORMALITY WERE OBSERVED. LOT 1018233,1025373, 1082985 EACH 30PCS RETAINED SAMPLES WERE TESTED ON ADDITIVE AMOUNT, ALL RESULT MEET THE PRODUCT SPECIFICATION. THERE WERE NO DIFFICULTIES ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE (OIL GEL GLOBULES) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OIL GEL GLOBULES OR ADDITIVE ABNORMALITY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1018233. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2021-02-01. MEDICAL DEVICE LOT #: 1025373. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2021-02-01. MEDICAL DEVICE LOT #: 1082985. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2021-04-01. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST BLOOD COLLECTION TUBE THERE WAS OIL GEL GLOBULES. THIS EVENT WAS REPORTED TO HAVE AFFECTED (B)(4) DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE TUBE WAS FOUND TO HAVE AN ADDITIVE ABNORMALITY ISSUE." ADDITIONAL INFORMATION (B)(6) 2021: THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: "THE YELLOW TUBE BLOCKED THE BIOCHEMICAL ANALYZER CAUSING AN ALAR. FLOATING OIL CAUSE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST BLOOD COLLECTION TUBE THERE WAS OIL GEL GLOBULES AND DISCOLORED/ABNORMAL ADDITIVE FORM. THIS EVENT WAS REPORTED TO HAVE AFFECTED 7002 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE TUBE WAS FOUND TO HAVE AN ADDITIVE ABNORMALITY ISSUE." ADDITIONAL INFORMATION 12/10/21: THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: "THE YELLOW TUBE BLOCKED THE BIOCHEMICAL ANALYZER CAUSING AN ALAR. FLOATING OIL CAUSE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST BLOOD COLLECTION TUBE THERE WAS OIL GEL GLOBULES. THIS EVENT WAS REPORTED TO HAVE AFFECTED 7002 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE TUBE WAS FOUND TO HAVE AN ADDITIVE ABNORMALITY ISSUE." ADDITIONAL INFORMATION (B)(6) 2021: THE DESCRIPTION OF THE INCIDENT WAS UPDATED AS FOLLOWS: "THE YELLOW TUBE BLOCKED THE BIOCHEMICAL ANALYZER CAUSING AN ALAR. FLOATING OIL CAUSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616418 BD VACUTAINER® SST BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1082985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown