BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8754382 · Received July 2, 2019

    Report

    Report Number
    1024879-2019-01106
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 25, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION RELATING TO LABEL LIFT THROUGH CAPA #1064141. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, 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. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA #1064141 TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). 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 THIS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LABELING ERROR OCCURRED BEFORE USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ACCORDING TO THE CLINICIAN: "WE ARE EXPERIENCING AN ISSUE WITH BD VACUTAINER SST BLOOD COLLECTION TUBES ITEM # 367986. THE PRODUCT LABELS ARE FALLING OFF OF THE INDIVIDUAL TUBES OF LOT # 9081740, EXP. 03/31/2020. WE OPENED TWO CASES AND THEIR PACKAGES TODAY AND FOUND THE LABEL EDGES ARE LIFTING AWAY FROM THE INDIVIDUAL TUBES. SOME HAVE FALLEN OFF COMPLETELY AND WE HAVE HAD TO DISCARD THOSE TUBES. ONCE THE LABELS FALL OFF THERE IS NO WAY OF KNOWING THE PRODUCT, ITS LOT, AND MORE IMPORTANTLY IT'S EXPIRATION DATE, THEREFORE MUST BE DISCARDED. WE JUST RECEIVED 5 NEW CASES OF A NEW LOT OF THE SAME PRODUCT AND OBSERVE THE SAME ISSUE OF THE EDGES OF THE LABEL NOT ADHERING TOTALLY. THAT LOT IS # 9095580, EXP. 03/31/2020."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9081740, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9095580, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2019-04-05. 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 LABELING ERROR OCCURRED BEFORE USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ACCORDING TO THE CLINICIAN: "WE ARE EXPERIENCING AN ISSUE WITH BD VACUTAINER SST BLOOD COLLECTION TUBES ITEM # 367986. THE PRODUCT LABELS ARE FALLING OFF OF THE INDIVIDUAL TUBES OF LOT # 9081740, EXP. 03/31/2020. WE OPENED TWO CASES AND THEIR PACKAGES TODAY AND FOUND THE LABEL EDGES ARE LIFTING AWAY FROM THE INDIVIDUAL TUBES. SOME HAVE FALLEN OFF COMPLETELY AND WE HAVE HAD TO DISCARD THOSE TUBES. ONCE THE LABELS FALL OFF THERE IS NO WAY OF KNOWING THE PRODUCT, ITS LOT, AND MORE IMPORTANTLY ITS EXPIRATION DATE, THEREFORE MUST BE DISCARDED. WE JUST RECEIVED 5 NEW CASES OF A NEW LOT OF THE SAME PRODUCT AND OBSERVE THE SAME ISSUE OF THE EDGES OF THE LABEL NOT ADHERING TOTALLY. THAT LOT IS # 9095580, EXP. 03/31/2020."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548081 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