BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8632789 · Received May 22, 2019

    Report

    Report Number
    1024879-2019-00900
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    May 7, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS 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. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER FOR THE 2 OTHER ISSUES ASSOCIATED WITH THIS COMPLAINT. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR LABEL LIFT WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION FOR THE UNKNOWN BATCHES, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: CAPA#1064141 HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THE LABEL LIFT ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THE LABEL LIFT ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE CORRECTION IS AS FOLLOWS: DATE RECEIVED BY MANUFACTURER: 2019-05-16.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LABEL ISSUES OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I NOTICED AN ANOMALY ON THE 5-50 GOLD SAMPLING TUBES REF: 367986. THE LABELS ON THE TUBES ARE NOT GLUED. THIS IS THE THIRD PACKAGE OF 100 FOR WHICH THERE IS THIS PROBLEM. I DO NOT HAVE THE LOT NUMBERS OF THE FIRST TWO PACKS, BUT THE LOT NUMBER FOR THE TUBES IN THE PHOTO BELOW IS 9030857 WITH THE EXPIRATION DATE 2020-01-31. IN ONE OF THE FIRST TWO PACKS OF 100, TUBES WERE MISSING FROM THE PACKAGE, PROBABLY BECAUSE THE LABELS WERE NOT GLUED.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LABEL ISSUES OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I NOTICED AN ANOMALY ON THE 5-50 GOLD SAMPLING TUBES REF: (B)(4). THE LABELS ON THE TUBES ARE NOT GLUED. THIS IS THE THIRD PACKAGE OF 100 FOR WHICH THERE IS THIS PROBLEM. I DO NOT HAVE THE LOT NUMBERS OF THE FIRST TWO PACKS, BUT THE LOT NUMBER FOR THE TUBES IN THE PHOTO BELOW IS 9030857 WITH THE EXPIRATION DATE 2020-01-31. IN ONE OF THE FIRST TWO PACKS OF 100, TUBES WERE MISSING FROM THE PACKAGE, PROBABLY BECAUSE THE LABELS WERE NOT GLUED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9030857, MEDICAL DEVICE EXPIRATION DATE: 2020-01-31, DEVICE MANUFACTURE DATE: 2019-01-30. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 LABEL ISSUES OCCURRED WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I NOTICED AN ANOMALY ON THE 5-50 GOLD SAMPLING TUBES REF: 367986. THE LABELS ON THE TUBES ARE NOT GLUED. THIS IS THE THIRD PACKAGE OF 100 FOR WHICH THERE IS THIS PROBLEM. I DO NOT HAVE THE LOT NUMBERS OF THE FIRST TWO PACKS, BUT THE LOT NUMBER FOR THE TUBES IS 9030857 WITH THE EXPIRATION DATE 2020-01-31. IN ONE OF THE FIRST TWO PACKS OF 100, TUBES WERE MISSING FROM THE PACKAGE, PROBABLY BECAUSE THE LABELS WERE NOT GLUED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427953 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other