BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 12448048 · Received September 9, 2021

    Report

    Report Number
    9617032-2021-00940
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 14, 2021
    Report Date
    October 13, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WAS UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 1151118. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2022. H.4. DEVICE MANUFACTURE DATE: 5/31/2021. H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TWENTY-FOUR (24) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO CLOSURE SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF CLOSURE SEPARATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE STOPPER WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE BD HEMOGARD SHIELD IS REMOVED FROM RUBBER STOPPER WHEN THE TUBES ARE SUPPOSED TO BE DECAPPED. THE COMPLETE CLOSURE SHOULD BE REMOVED, BUT THE RUBBER STOPPER REMAINS. THE INSTRUMENT IS THEN DAMAGED WHEN LATER ON, THE INSTRUMENT PROBE MOVES INTO THE TUBE AND IT CRASHES ON THE RUBBER STOPPER IN THE BD VACUTAINER TUBE.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD NOT RECEIVE SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THE STOPPER WAS DIFFICULT TO REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE BD HEMOGARD SHIELD IS REMOVED FROM RUBBER STOPPER WHEN THE TUBES ARE SUPPOSED TO BE DECAPPED. THE COMPLETE CLOSURE SHOULD BE REMOVED, BUT THE RUBBER STOPPER REMAINS. THE INSTRUMENT IS THEN DAMAGED WHEN LATER ON, THE INSTRUMENT PROBE MOVES INTO THE TUBE AND IT CRASHES ON THE RUBBER STOPPER IN THE BD VACUTAINER TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343827 BD VACUTAINER SST II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367953 1151118 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1