BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE TUBE

    MDR report key: 9505700 · Received December 20, 2019

    Report

    Report Number
    9617032-2019-01524
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    July 18, 2019
    Report Date
    January 13, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 0

    THE CHANGE IS AS FOLLOWS: DATE OF EVENT: (B)(6) 2019 .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNDERFILL OCCURRED DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE TUBE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT BD TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT TEST INTERVALS EVENT DESCRIPTION PER ATTACHED EMAIL STATES: AS PART OF CAPA 54720, WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. PLEASE REFER BELOW GRAPHS FOR DETAILS. AND ALSO REFER THE TABLE FOR YOUR REFERENCE. IRRADIATION DOSE (KGY): MAXIMUM 30.0-31.0 TEST INTERVAL (MONTHS): T=17."

    Description of Event or Problem · 0

    MATERIAL NO: 368970 BATCH NO: 8025616. IT WAS REPORTED THAT BD TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT TEST INTERVALS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: AS PART OF CAPA 54720, WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. PLEASE REFER BELOW GRAPHS FOR DETAILS. AND ALSO REFER THE TABLE FOR YOUR REFERENCE. IRRADIATION DOSE (KGY): MAXIMUM 30.0-31.0. TEST INTERVAL (MONTHS): T=17.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 UNDERFILL OCCURRED DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE TUBE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT BD TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT TEST INTERVALS. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: AS PART OF CAPA 54720, WE SOURCED BD VACUTAINER® SST 5.0 ML (368970), 3.5 ML (368967) AND 6.0 ML (366444) TUBES WHICH WERE STERILIZED AT NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY) FOR DRAW VOLUME TESTING. THE TESTING INDICATES BOTH NOMINAL AND MAXIMUM DOSED BD VACUTAINER® SST 5.0, 3.5 AND 6.0 ML TUBES DID NOT MEET THE PRODUCT SPECIFICATION FOR DRAW VOLUME OF -19% OF LABELLED DRAW AT BELOW MENTIONED TEST INTERVALS. PLEASE REFER BELOW GRAPHS FOR DETAILS. AND ALSO REFER THE TABLE FOR YOUR REFERENCE. IRRADIATION DOSE (KGY): MAXIMUM 30.0-31.0 TEST INTERVAL (MONTHS): T=17."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302609 BD VACUTAINER® SST¿ II ADVANCE TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8025616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other