BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CIT PLH 13X75 1.8 PLBL CE L/BL .109

    MDR report key: 10089588 · Received May 26, 2020

    Report

    Report Number
    9617032-2020-00436
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    April 14, 2020
    Report Date
    June 11, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630474
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY 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 FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: DATE RECEIVED BY MANUFACTURER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1000 TUBES CIT PLH 13X75 1.8 PLBL CE L/BL .109 WERE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNDERFILLED TUBES OBSERVED DURING THE COLLECTION, DUE TO MAYBE LESS VACUUM ON THE TUBES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1000 TUBES CIT PLH 13X75 1.8 PLBL CE L/BL .109 WERE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNDERFILLED TUBES OBSERVED DURING THE COLLECTION, DUE TO MAYBE LESS VACUUM ON THE TUBES."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1000 TUBES CIT PLH 13X75 1.8 PLBL CE L/BL .109 WERE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNDERFILLED TUBES OBSERVED DURING THE COLLECTION, DUE TO MAYBE LESS VACUUM ON THE TUBES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553786 TUBE CIT PLH 13X75 1.8 PLBL CE L/BL .109 BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363047 8348673 50382903630474

    Patients

    Seq Age Sex Outcome Treatment
    1 Other