BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 11545021 · Received March 22, 2021

    Report

    Report Number
    1024879-2021-00203
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-15. H6: INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE AND 1 PHOTO FOR INVESTIGATION OF MATERIAL # 367812, BATCH # 0100893. THE PHOTO AND CUSTOMER SAMPLE WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING LABEL ON THE TUBE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, 72 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING LABEL ON THE TUBE WAS NOT OBSERVED. SEVENTY-TWO (72) OUT OF 72 RETENTION SAMPLES HAD LABELS ON THE TUBES. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO INADEQUATELY PURGING OF THE MANUFACTURING LINE DURING EITHER A LABEL ROLL CHANGE OR AN EQUIPMENT ADJUSTMENT. 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. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "BEFORE USE, THERE WAS NO LABEL FOUND ON THE DEVICE."

    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 WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBE THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "BEFORE USE, THERE WAS NO LABEL FOUND ON THE DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439574 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 0100893 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1