BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11509988 · Received March 17, 2021

    Report

    Report Number
    1024879-2021-00190
    Event Type
    Malfunction
    Date Received
    March 17, 2021
    Date of Event
    February 18, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H6: IMDRF ANNEX B GRID: B02. H6: IMDRF ANNEX C GRID: C16. H6: IMDRF ANNEX D GRID: D03. H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 29 RETENTION SAMPLES (FOR EACH LOT) FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND ISSUES WERE OBSERVED RELATING TO 'STOPPER POP OFF'. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF 'STOPPER POP OFF' THROUGH CORRECTIVE AND PREVENTIVE ACTIONS (CAPA PR # 1875009).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD THE STOPPER CREEP OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367983, BATCH NO. 0352914 AND 1011403. IT IS REPORTED CUSTOMER EXPERIENCED STOPPERS ARE NOT STAYING ON. WE RECENTLY HAVING ISSUE WITH BD VACUTAINER TUBES AS CAPS IS NOT STAYING ON SST TUBE. SOME OF THE TUBES DROPPED BY STAFF AND BLOOD SPILLED, THIS HAPPENS WHEN THEY SQUIRT THE SYRINGES INTO THE SST AND FOR THAT THEY NEED TO REMOVE THE CAP WHICH RELEASES VACUUM. THIS IS BEING HAPPENING FOR QUITE A FEW DAYS NOW. THERE WAS NO ISSUE WITH ANY OTHER LOT OF THE SST BEFORE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD THE STOPPER CREEP OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367983, BATCH NO. 0352914 AND 1011403. IT IS REPORTED CUSTOMER EXPERIENCED STOPPERS ARE NOT STAYING ON. WE RECENTLY HAVING ISSUE WITH BD VACUTAINER TUBES AS CAPS IS NOT STAYING ON SST TUBE. SOME OF THE TUBES DROPPED BY STAFF AND BLOOD SPILLED, THIS HAPPENS WHEN THEY SQUIRT THE SYRINGES INTO THE SST AND FOR THAT THEY NEED TO REMOVE THE CAP WHICH RELEASES VACUUM. THIS IS BEING HAPPENING FOR QUITE A FEW DAYS NOW. THERE WAS NO ISSUE WITH ANY OTHER LOT OF THE SST BEFORE"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. INITIAL REPORTER PHONE NUMBER: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0352914. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2020-12-17. MEDICAL DEVICE LOT #: 1011403. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2021-01-11.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD THE STOPPER CREEP OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367983, BATCH NO. 0352914 AND 1011403. IT IS REPORTED CUSTOMER EXPERIENCED STOPPERS ARE NOT STAYING ON. WE RECENTLY HAVING ISSUE WITH BD VACUTAINER TUBES AS CAPS IS NOT STAYING ON SST TUBE. SOME OF THE TUBES DROPPED BY STAFF AND BLOOD SPILLED, THIS HAPPENS WHEN THEY SQUIRT THE SYRINGES INTO THE SST AND FOR THAT THEY NEED TO REMOVE THE CAP WHICH RELEASES VACUUM. THIS IS BEING HAPPENING FOR QUITE A FEW DAYS NOW. THERE WAS NO ISSUE WITH ANY OTHER LOT OF THE SST BEFORE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403905 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367983 SEE H.10. 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1