BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD® EXTENSION SETS

    MDR report key: 6304315 · Received February 6, 2017

    Report

    Report Number
    3012307300-2017-00374
    Event Type
    Injury
    Date Received
    February 6, 2017
    Report Date
    March 9, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DETAILED THAT THIS INCIDENT HAD BEEN CAPTURED PREVIOUSLY. THE FOLLOWING IS A LIST OF REPORTED MFRS RELATED TO THIS MDR: 3012307300-2017-00404, 3012307300-2017-00405, 3012307300-2017-00406, 3012307300-2017-00407, 3012307300-2017-00408, 3012307300-2017-00409, 3012307300-2017-00410, 3012307300-2017-00411, 3012307300-2017-00412, 3012307300-2017-00413, 3012307300-2017-00414, 3012307300-2017-00415, 3012307300-2017-00416, 3012307300-2017-00417, 3012307300-2017-00418, 3012307300-2017-00419, 3012307300-2017-00421, 3012307300-2017-00422, 3012307300-2017-00423, 3012307300-2017-00659, 3012307300-2017-00660, 3012307300-2017-00661, 3012307300-2017-00662, 3012307300-2017-00663, 3012307300-2017-00664, AND 3012307300-2017-00665 UPON FURTHER REVIEW, THIS FILE IS CONSIDERED A DUPLICATE AND IT IS NOT CONSIDERED A REPORTABLE EVENT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    VOLUNTARY MEDWATCH SUBMISSION #: MW5066839. AGE AT TIME OF EVENT: 18-90 YEARS OLD. THE REPORTER NOTED THE DATE (B)(6) 2015 AND THEN NOTED THE ISSUES WERE REPORTED "FROM (B)(6) UNTIL TODAY". POTENTIAL CATALOG NUMBER: 7036. POTENTIAL LOT NUMBER: THE REPORTER NOTED THAT THE EXTENSION SET AFFECTED WAS MANUFACTURED PRIOR TO LOT 46X824. CUSTOMER HAS NOT RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. 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

    IT WAS REPORTED THAT A CADD® EXTENSION SET WAS LEAKING. THE DEVICE WAS IN USE WITH A HOME CARE PATIENT. THE PATIENT REQUIRED ADDITIONAL TREATMENT. THE SET HAD TO BE CHANGED OR PROLONGED TREATMENT AND ADMITTANCE TO THE HOSPITAL OCCURRED. IT IS UNCLEAR WHAT THE IMPACT TO THE PATIENT WAS. SEE MFR: 3012307300-2017-00362, 3012307300-2017-00363, 3012307300-2017-00364, 3012307300-2017-00365, 3012307300-2017-00366, 3012307300-2017-00367, 3012307300-2017-00368, 3012307300-2017-00369, 3012307300-2017-00370, 3012307300-2017-00371, 3012307300-2017-00372, 3012307300-2017-00373, 3012307300-2017-00374, 3012307300-2017-00375, 3012307300-2017-00376, 3012307300-2017-00377, 3012307300-2017-00378, 3012307300-2017-00379, 3012307300-2017-00380, 3012307300-2017-00381, AND 3012307300-2017-00382.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88400 CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R