BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 12527562 · Received September 24, 2021

    Report

    Report Number
    1024879-2021-00667
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 30, 2021
    Report Date
    December 8, 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
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: FROM: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0286251. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. H.4. DEVICE MANUFACTURE DATE:2020-10-12. D.4. MEDICAL DEVICE LOT #: 0287676. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. H.4. DEVICE MANUFACTURE DATE: 2020-10-13. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. TO: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0286251. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. H.4. DEVICE MANUFACTURE DATE:2020-10-12. D.4. MEDICAL DEVICE LOT #: 0287676. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. H.4. DEVICE MANUFACTURE DATE: 2020-10-13.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TWENTY-NINE (29) RETENTION SAMPLES FROM EACH BATCH # 0287676 AND 0286251 FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL STOPPER PULLOUT TESTING AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR STOPPER POP OFF WAS OBSERVED FOR BOTH BATCH # 0287676 AND 0286251. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF STOPPER POP OFF BASED ON RETENTION SAMPLE TESTING. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF STOPPER FUNCTION DEFECTS THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. CAPA #3741863 HAS BEEN INITIATED FOR FURTHER INVESTIGATION OF SERUM STOPPER CREEP OUT COMPLAINTS. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POPPING OFF. THIS EVENT OCCURRED 250 TIMES WITH LOT; 0286251. THIS EVENT OCCURRED 250 TIMES WITH LOT: 0287676. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PROBLEM THAT IS HAPPENING IS THAT WHEN THE TUBES ARE OPENED AND LOST THE VACUUM, IT NOT POSSIBLE TO RECAP THEM ANYMORE, THEY OPEN. THEY WORK WITH THE SERUM TUBES, WHICH THEY REMOVE THE CAP TO COLLECT THE SAMPLE IN A OPEN WAY (WITHOUT USING THE VACUUM) - 3 TUBES WERE DELIVERED FROM THE BATCH 0287676, AND IN 2 OF THEM AFTER RECAPPING, THE TUBES ARE OPENING AFTER A WHILE; - THE SAMPLE COLLECTORS HAVEN'T CHANGED; TUBES ARE NO LONGER AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POPPING OFF. THIS EVENT OCCURRED 250 TIMES WITH LOT; 0286251. THIS EVENT OCCURRED 250 TIMES WITH LOT: 0287676. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PROBLEM THAT IS HAPPENING IS THAT WHEN THE TUBES ARE OPENED AND LOST THE VACUUM, IT NOT POSSIBLE TO RECAP THEM ANYMORE, THEY OPEN. THEY WORK WITH THE SERUM TUBES, WHICH THEY REMOVE THE CAP TO COLLECT THE SAMPLE IN A OPEN WAY (WITHOUT USING THE VACUUM): 3 TUBES WERE DELIVERED FROM THE BATCH 0287676, AND IN 2 OF THEM AFTER RECAPPING, THE TUBES ARE OPENING AFTER A WHILE: THE SAMPLE COLLECTORS HAVEN'T CHANGED; TUBES ARE NO LONGER AVAILABLE.

    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 #: 0286251, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE:2020-10-12, MEDICAL DEVICE LOT #: 0287676, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2020-10-13, 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 WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED STOPPER POPPING OFF. THIS EVENT OCCURRED 250 TIMES WITH LOT; 0286251. THIS EVENT OCCURRED 250 TIMES WITH LOT: 0287676. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PROBLEM THAT IS HAPPENING IS THAT WHEN THE TUBES ARE OPENED AND LOST THE VACUUM, IT NOT POSSIBLE TO RECAP THEM ANYMORE, THEY OPEN. THEY WORK WITH THE SERUM TUBES, WHICH THEY REMOVE THE CAP TO COLLECT THE SAMPLE IN A OPEN WAY (WITHOUT USING THE VACUUM) 3 TUBES WERE DELIVERED FROM THE BATCH 0287676, AND IN 2 OF THEM AFTER RECAPPING, THE TUBES ARE OPENING AFTER A WHILE; THE SAMPLE COLLECTORS HAVEN'T CHANGED; TUBES ARE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423957 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 SEE H.10. 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown