BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRIPPER MICRO-BLUNT CANNULA SAFETY NEEDLE

    MDR report key: 3810402 · Received April 14, 2014

    Report

    Report Number
    2183502-2014-00211
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FPA
    PMA / PMN Number
    K072059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING THAT FOLLOWING PLACEMENT OF THE DEVICE FOR INFUSION OF MEDICATION, THE NEEDLE OF THE INSERTION DEVICE WAS UNABLE TO BE RETRACTED INTO THE SAFETY POSITION. NO ADVERSE EFFECTS TO PATIENT OR USER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228123 GRIPPER MICRO-BLUNT CANNULA SAFETY NEEDLE FPA SMITHS MEDICAL 21-3521 33X859

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PORT-A-CATH