BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEC 20DP, TEXIUM & HANGER V/NV

    MDR report key: 11599965 · Received March 31, 2021

    Report

    Report Number
    9616066-2021-50631
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 6, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403225628
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE SAMPLES WERE SUBMITTED FOR QUALITY INVESTIGATION FROM LOT# 20046279. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS VERIFIED BY VISUAL INSPECTION. EVALUATION OF THE SAMPLES SUBMITTED SHOW THAT THE MALE LUERS HAD A WHITE FOREIGN MATTER OVER THE ENTIRE BODY OF THE MALE LUER CONNECTION. THE ROOT CAUSE FOR THIS ISSUE IS AN EXCESSIVE AMOUNT OF THE EPOXY BEING USED TO CONNECT THE MALE LUER CONNECTOR (P/N 1001-143-022) TO THE TUBING (P/N 620-00065). FIFTEEN SAMPLES WERE SUBMITTED FOR QUALITY INVESTIGATION FROM LOT#20095691. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS VERIFIED BY VISUAL INSPECTION. EVALUATION OF THE SAMPLES SUBMITTED SHOW THAT THE MALE LUERS HAD A WHITE FOREIGN MATTER OVER THE ENTIRE BODY OF THE MALE LUER CONNECTION (P/N 1001-143-022). THE ROOT CAUSE FOR THIS ISSUE IS AN EXCESSIVE AMOUNT OF THE EPOXY BEING USED TO CONNECT THE MALE LUER CONNECTOR (P/N 1001-143-022) TO THE TUBING (P/N 620-00065). A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #20095691 REGARDING ITEM #40000-07T. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #20046279 REGARDING ITEM #40000-07T. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEC 20DP, TEXIUM & HANGER V/NV HAD FOREIGN MATTER. THIS OCCURRED ON 19 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 40000-07T, BATCH NO: 20046279 , 20065116 , 20095691. IT WAS REPORTED THAT THERE IS WHITE RESIDUE ON THE MALE LEUR.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20046279. MEDICAL DEVICE EXPIRATION DATE: 2023-04-28. DEVICE MANUFACTURE DATE: 2020-04-15. MEDICAL DEVICE LOT #: 20065116. MEDICAL DEVICE EXPIRATION DATE: 2023-06-09. DEVICE MANUFACTURE DATE: 2020-05-28. MEDICAL DEVICE LOT #: 20095691. MEDICAL DEVICE EXPIRATION DATE: 2023-09-07. DEVICE MANUFACTURE DATE: 2020-09-02. 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 SEC 20DP, TEXIUM & HANGER V/NV HAD FOREIGN MATTER. THIS OCCURRED ON 19 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 40000-07T BATCH NO: 20046279 , 20065116 , 20095691. IT WAS REPORTED THAT THERE IS WHITE RESIDUE ON THE MALE LEUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493144 SEC 20DP, TEXIUM & HANGER V/NV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H.10 10885403225628

    Patients

    Seq Age Sex Outcome Treatment
    1