BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC

    MDR report key: 10977870 · Received December 9, 2020

    Report

    Report Number
    3012307300-2020-12238
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 10, 2020
    Report Date
    January 18, 2021
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586025594
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC GRIPPER PLUS NEEDLES. FOUR PICTURES WITH P/N 21-2766-24 L/N 3967853 WERE REVIEWED AND FOUND NOT POSSIBLE TO EVALUATE PROBLEM WITH SAFETY ARM ON PICTURES. SAMPLES WERE OBTAINED AND FOUND WHEN ACTIVATING THE SAFETY ARM, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS BELIEVED TO BE IN REV.100 THE OCCURRENCE FOR THIS FAILURE CONDITION ?OPERATOR NOT FOLLOWING THE PROCEDURE". THE ENGINEERING PROCESS AND TESTING PRIOR TO RELEASE OF PRODUCT WAS REVIEWED AND FOUND ALL PRODUCT PASSED AT 100% WITH NO DISCREPANCIES. ISSUE CONFIRMED AND REPORTED MONITORING WILL BE IN PLACE ON ANY FURTHER ISSUES WITH PRODUCT.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A IMPLANTABLE PORTS/DELTEC GRIPPER PLUS NEEDLES HAD AN EXPOSED NEEDLE THAT WOULD NOT RETRACT BACK INTO THE SAFETY ARM. THIS OCCURRED DURING USE, NO PATIENT INJURY OCCURRED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440287 DELTEC GRIPPERS NEEDLES FPA ST PAUL 21-2766-24 3967853 10610586025594

    Patients

    Seq Age Sex Outcome Treatment
    1