BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST II PLH 13X100 5.0 PLBL CE NAT

    MDR report key: 9490737 · Received December 18, 2019

    Report

    Report Number
    9617032-2019-01482
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    September 10, 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

    CORRECTION: THE DATE OF EVENT HAS BEEN PROVIDED BY THE CUSTOMER. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DATE OF EVENT: (B)(6) 2019.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 TUBES SST II PLH 13X100 5.0 PLBL CE NAT DID NOT MEET PRODUCT SPECIFICATIONS FOR DRAW VOLUME OF "-19%" OF LABELLED DRAW DURING TEST INTERVALS. THE TUBES WERE STERILIZED AT "NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY)" FOR DRAW VOLUME TESTING AS PART OF CAPA# 54720. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 TUBES SST II PLH 13X100 5.0 PLBL CE NAT DID NOT MEET PRODUCT SPECIFICATIONS FOR DRAW VOLUME OF "-19%" OF LABELLED DRAW DURING TEST INTERVALS. THE TUBES WERE STERILIZED AT "NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY)" FOR DRAW VOLUME TESTING AS PART OF CAPA# 54720. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "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."

    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 60 TUBES SST II PLH 13X100 5.0 PLBL CE NAT DID NOT MEET PRODUCT SPECIFICATIONS FOR DRAW VOLUME OF "-19%" OF LABELLED DRAW DURING TEST INTERVALS. THE TUBES WERE STERILIZED AT "NOMINAL (~22.6 KGY) AND MAXIMUM DOSE LEVELS (~32.3 KGY)" FOR DRAW VOLUME TESTING AS PART OF CAPA# 54720. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AS PART OF CAPA (B)(4), 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286736 TUBE SST II PLH 13X100 5.0 PLBL CE NAT BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8025616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other