BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10646165 · Received October 7, 2020

    Report

    Report Number
    9616066-2020-20031
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 15, 2020
    Report Date
    November 5, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233904
    PMA / PMN Number
    K811885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : IT WAS REPORTED THAT THE TUBING OF MODEL #10014914, BATCH #20065193 DOES NOT ALLOW FLUID TO FLOW THROUGH THE LINE. AN INVESTIGATION WAS PERFORMED. THE SET WAS UNABLE TO BE PRIMED AND ANALYZED FOR DEFECTS. VISUAL INSPECTION UNDER MAGNIFICATION OF THE ENGAGEMENT BETWEEN THE TUBING AND FEMALE LUER OBSERVED AN OCCLUSION. THE ROOT CAUSE WAS SOLVENT TRAPPED BETWEEN THE EDGE OF THE TUBING AND THE FEMALE LUER COMPONENT BONDING POCKET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 LOT NUMBER 20065193 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF 12,003 UNITS IN 1 LOT NUMBER WAS BUILT ON 03JUN2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WOULD NOT FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 ORIGINATED FROM BAG 6: CUSTOMER SENT ONE OPEN-PACKAGE 10014914, LOT NUMBER: 20065193". THE CUSTOMER INCLUDED A STICKY NOTE STATING "TUBING WOULD NOT FLUSH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SYR PSD MICROBORE TUBING WOULD NOT FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVENT 1 ORIGINATED FROM BAG 6: CUSTOMER SENT ONE OPEN-PACKAGE 10014914, LOT NUMBER: 20065193". THE CUSTOMER INCLUDED A STICKY NOTE STATING "TUBING WOULD NOT FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108566 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 20065193 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other