BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRA GRAFT, 6MM W/GRAD REINFORCE

    MDR report key: 7010667 · Received November 8, 2017

    Report

    Report Number
    2916596-2017-02676
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 27, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PART AND LOT NUMBERS: PART # 10002-6040-001, LOT # 198403-1, QUANTITY: 25, LOT # 198403-2, QUANTITY: 24, LOT # 198403-3, QUANTITY: 21. THE PRODUCTS WERE RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. THE EVENT OCCURRED IN (B)(6). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION. THE PART NUMBER OF THE DEVICE WAS CORRECTED FROM 10002-6040-001 TO 10007187. THE REPORTED EVENT OF INCORRECT PACKAGE LABELING WAS CONFIRMED. THE CALL-OUT FOR THE DIAMETER ON THE BOTTOM FLAP WAS INCORRECTLY LABELED AS 5.0 MM IN DIAMETER INSTEAD OF 6.0 MM. THE OTHER DIAMETER CALL-OUTS ON THE LABELS WERE CORRECT. THE LABEL PRINTING FILE FOR THE PART'S LABEL WAS FOUND TO BE INCORRECT AND WAS REVISED TO CORRECTLY HAVE THE PROPER DIAMETER ON THE BOTTOM FLAP. THE PRODUCTS WERE NOT IN USE AT THE TIME OF THE EVENT. THE ISSUE WITH THE OUTER CARTON LABELING WAS OBSERVED WHEN THE VECTRA GRAFTS WERE RECEIVED BY THE HOSPITAL. THE RETURNED PRODUCTS WERE REWORKED AND SENT BACK TO THE HOSPITAL. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON RECEIPT OF THE PRODUCTS, INCORRECT LABELING WAS DISCOVERED ON THE OUTSIDE OF THE BOXES. THE DIAMETER AND LENGTH MEASUREMENTS WERE LISTED INCORRECTLY ON TWO SECTIONS OF THE LABEL ON THE OUTSIDE OF THE BOX. THE PATIENT LABELS AND LABELS ON THE TRAYS WERE CORRECT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791104 VECTRA GRAFT, 6MM W/GRAD REINFORCE VECTRA GRAFT DSQ THORATEC CORPORATION 198403-1

    Patients

    Seq Age Sex Outcome Treatment
    1