BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ VIAL ACCESS DEVICE (NEEDLE FREE)

    MDR report key: 14000592 · Received April 4, 2022

    Report

    Report Number
    9616066-2022-00355
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 8, 2022
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 25-MAR-2022. H6: INVESTIGATION SUMMARY: TWO 2202E-0006 SAMPLES FROM LOT 20106342 WERE RECEIVED FOR INVESTIGATION; ONE SAMPLE WAS RECEIVED IN SEALED PACKAGING AND THE SECOND SAMPLE WAS RECEIVED IN OPENED PACKAGING WITH NO RESIDUAL FLUID IN LINE. AS PART OF THE FEEDBACK, THE CUSTOMER PROVIDED SOME PHOTOGRAPHS OF THE AFFECTED SAMPLES ANALYSIS OF THE PHOTOGRAPHS CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE ACCESS PIN IDENTIFIED TO BE MISSING. A VISUAL INSPECTION OF THE RETURNED SAMPLES CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE ACCESS PIN MISSING IN EACH INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THEY CONFIRMED THAT THE ACCESS PIN COMPONENT IS AUTOMATICALLY ASSEMBLED ONTO THE BODY OF THE 2202E-0006 PRODUCT, DURING ASSEMBLY A SENSOR WITHIN THE AUTOMATIC ASSEMBLY MACHINE DETECTS THE PRESENCE OF THE SPIKE AND APPLIES SOLVENT; IN THIS INSTANCE IT IS POSSIBLE THAT THE SENSOR WAS MISALIGNED, WHICH MEANT THAT THE SPIKE WAS NOT DETECTED AND THEREFORE NO SOLVENT WAS APPLIED TO THE COMPONENT. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20106342 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IN ORDER TO ENSURE THAT REPORTS OF THIS NATURE ARE REDUCED IN FUTURE, VARIOUS IMPROVEMENT ACTIONS WERE PERFORMED ON THE AUTOMATIC ASSEMBLY MACHINE WHICH SHOULD ENSURE THAT REPORTS OF THIS NATURE ARE REDUCED IN FUTURE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED OCCURRENCE WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 2202E-0006 PRODUCT OVER THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ VIAL ACCESS DEVICE (NEEDLE FREE) WAS MISSING A WHITE ACCESS PIN. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE ACCESS PIN MISSING FROM PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ VIAL ACCESS DEVICE (NEEDLE FREE) WAS MISSING A WHITE ACCESS PIN. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE ACCESS PIN MISSING FROM PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78095 BD¿ VIAL ACCESS DEVICE (NEEDLE FREE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20106342

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown