BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEC SET 20DP 30IN W/HANGER LL

    MDR report key: 15819901 · Received November 17, 2022

    Report

    Report Number
    9616066-2022-01761
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 25, 2022
    Report Date
    December 22, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203010078
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED BY CUSTOMER THAT "SECONDARY SETS ARE CAUSING ISSUES WITH MED INFUSIONS. THE FILTER ISN¿T ALLOWING FOR PROPER INFUSION." THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 72213N LOT NUMBER 22079234 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 200 BD SEC SET 20DP 30IN W/HANGER LL WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSING IS STATING THAT THE SECONDARY SETS ARE CAUSING ISSUES WITH MED INFUSIONS. THE FILTER ISN¿T ALLOWING FOR PROPER INFUSION OF A SECONDARY WHEN ADMINISTERING WITH A GLASS BOTTLE (A FEW MEDS COME IN BOTTLES).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 200 BD SEC SET 20DP 30IN W/HANGER LL WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSING IS STATING THAT THE SECONDARY SETS ARE CAUSING ISSUES WITH MED INFUSIONS. THE FILTER ISN¿T ALLOWING FOR PROPER INFUSION OF A SECONDARY WHEN ADMINISTERING WITH A GLASS BOTTLE (A FEW MEDS COME IN BOTTLES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199670 BD SEC SET 20DP 30IN W/HANGER LL INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 72213N 22079234 07613203010078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown