BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS SYR PSD MICROBORE

    MDR report key: 10910032 · Received November 26, 2020

    Report

    Report Number
    9616066-2020-20478
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 3, 2020
    Report Date
    December 1, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF A CRACKED AND LEAKING EXTENSION SET WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS RETURNED FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE SAMPLE NO DEFECTS COULD BE FOUND. THE SET WAS THEN PRIMED AND A LEAK WAS DISCOVERED BELOW THE BLUE CAP; THE CUSTOMER'S COMPLAINT WAS VERIFIED. THE SET WAS THEN INSPECTED USING A MICROSCOPE AND THE CRACK IN THE SET WAS FOUND AT THE BOTTOM OF THE CAP. A DEVICE HISTORY RECORD REVIEW FOR MODEL 10014914 LOT NUMBER 4934725 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF COMPONENT DAMAGE WITH LOT #4934725 REGARDING ITEM #10014914. POSSIBLE ROOT CAUSES FOR THIS ERROR INCLUDE ERROR IN THE MANUFACTURING PROCESS AND EXCESSIVE FORCE APPLIED DURING REMOVAL OF CAP. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING WAS BROKEN AND LEAKED AT THE CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN LEAKING BLUE CAP AT CONNECTION OF TUBING."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AS SYR PSD MICROBORE TUBING WAS BROKEN AND LEAKED AT THE CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN LEAKING BLUE CAP AT CONNECTION OF TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377063 AS SYR PSD MICROBORE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10014914 UNKNOWN 50885403233904

    Patients

    Seq Age Sex Outcome Treatment
    1