BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM

    MDR report key: 11325375 · Received February 12, 2021

    Report

    Report Number
    9616066-2021-50228
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 16, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A 8100-027 SAMPLE WAS NOT REQUIRED FOR INVESTIGATION OF THIS FEEDBACK AS THE CUSTOMER PROVIDED PHOTOGRAPHS OF THE AFFECTED SAMPLES; ANALYSIS OF THE PHOTOGRAPHS CONFIRMED THE CUSTOMER'S EXPERIENCE WITH TWO DIFFERENT TYPES OF COMPONENT IDENTIFIED WITHIN THE BULK PACKAGING. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THEY CONFIRMED THAT IT IS POSSIBLE THAT THE MIXED PRODUCT OCCURRED DUE TO INCORRECT SEGREGATION OF THE TWO COMPONENTS FOLLOWING THE ASSEMBLY PROCESS; THE SEGREGATION PROCESS IS A MANUAL PROCEDURE AND IS LIKELY TO HAVE OCCURRED DUE TO HUMAN ERROR. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20108173 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 8100-027 PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1500 ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM HAD A MIX OF PRODUCT TYPES IN A PACK BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "MIXED PRODUCT - PER THE ATTACHED. CUSTOMER WAS SENT THIS LOT 2 X'S: 60K PCS IN OCT 2020 ; 30K PCS IN DEC 2020."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1500 ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM HAD A MIX OF PRODUCT TYPES IN A PACK BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "MIXED PRODUCT. CUSTOMER WAS SENT THIS LOT 2 X'S: (B)(4) PCS IN OCT 2020 ; (B)(4) PCS IN DEC 2020."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220773 ASSEMBLY NAC-Y SITE (0.088 TUBING) OEM INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20108173

    Patients

    Seq Age Sex Outcome Treatment
    1