BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM SS 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 10795487 · Received November 5, 2020

    Report

    Report Number
    9616066-2020-20263
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 13, 2020
    Report Date
    March 16, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-04. INVESTIGATION SUMMARY: (B)(4) OE0420R SAMPLE FROM LOT 202028 WAS RECEIVED FOR INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THAT THE CRACKS REPORTED BY THE CUSTOMER WERE VISIBLE GLUE FROM THE UV CURING PROCESS, AND NOT DAMAGE TO THE COMPONENT. THE SAMPLE WAS SUBJECTED TO FUNCTIONAL TESTING WHICH CONFIRMED THAT THE DEFECT DID NOT AFFECT THE FUNCTIONALITY OR INTEGRITY OF THE DEVICE AND IS DEEMED COSMETIC IN NATURE. INVESTIGATION PERFORMED BY THE SUPPLIER OF THE DEVICE CONFIRMED THAT THE VISIBLE GLUE IS LIKELY TO HAVE OCCURRED AS A RESULT OF THE UV GLUE HAVING NOT BEEN CURED SUFFICIENTLY DURING THE MANUFACTURING PROCESS. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202028 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 REPORTS OF THIS NATURE DO NOT OCCUR IN FUTURE, THE MANUFACTURING SITE HAVE IMPLEMENTED ADDITIONAL IN-PROCESS CHECKS DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH THIS CUSTOMER BEING THE ONLY CUSTOMER TO PROVIDE THIS TYPE OF FEEDBACK AGAINST THE OE0420R PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OEM SS 20MM VENTED VIAL ACCESS DEVICE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: OE0420R, BATCH/ LOT #: 202028 IT WAS REPORTED THAT THE THERE WERE CRACKS FOUND WHEN INSPECTING THE VIAL ADAPTERS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 OEM SS 20MM VENTED VIAL ACCESS DEVICE WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: OE0420R BATCH/ LOT #: 202028 IT WAS REPORTED THAT THE THERE WERE CRACKS FOUND WHEN INSPECTING THE VIAL ADAPTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254856 OEM SS 20MM VENTED VIAL ACCESS DEVICE VIAL ACCESS DEVICE LHI SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 202028

    Patients

    Seq Age Sex Outcome Treatment
    1