BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 9481958 · Received December 17, 2019

    Report

    Report Number
    1024879-2019-02124
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    December 1, 2019
    Report Date
    February 10, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678155
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS AND SAMPLES WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR LABEL LIFT WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#1064141 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION RECEIVED DURING INVESTIGATION: MEDICAL DEVICE LOT #: 9210555. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2019-07-29.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS ARE LIFTING WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THIS OCCURRED ON 80000 SEPARATE TUBES AFTER USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMERS RAISED THE COMPLAINT OF LABEL ARE NOT PROPERLY FIX ON TUBES AND SOME OF THE TUBE STUCK IN THE SORTER BECAUSE OF THIS TURN AROUND TIME IS LENGTHIER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS ARE LIFTING WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THIS OCCURRED ON 80000 SEPARATE TUBES AFTER USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMERS RAISED THE COMPLAINT OF LABEL ARE NOT PROPERLY FIX ON TUBES AND SOME OF THE TUBE STUCK IN THE SORTER BECAUSE OF THIS TURN AROUND TIME IS LENGTHIER.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE LABELS ARE LIFTING WITH A BD VACUTAINER® SERUM BLOOD COLLECTION TUBES. THIS OCCURRED ON 80000 SEPARATE TUBES AFTER USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMERS RAISED THE COMPLAINT OF LABEL ARE NOT PROPERLY FIX ON TUBES AND SOME OF THE TUBE STUCK IN THE SORTER BECAUSE OF THIS TURN AROUND TIME IS LENGTHIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279880 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367815 9210555 50382903678155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other