BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE VIAL ACCESS DEVICE VENTED WITH SS

    MDR report key: 15611075 · Received October 14, 2022

    Report

    Report Number
    9616066-2022-01548
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 17, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: 10-OCT-2022. INVESTIGATION SUMMARY: EIGHT MV0400-0006 SAMPLES WERE RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; THE SAMPLES WERE REPORTED AS BEING FROM LOTS 202048 AND 202031. THE SAMPLES WERE RECEIVED WITH THE PROTECTIVE CAPS OVER THE SPIKES. THE CUSTOMER HAS REPORTED THAT THEY OBSERVED FLUID BLOCKAGE AND THAT IT WAS SOMETIMES NECESSARY TO APPLY EXTRA PRESSURE WITH THE SYRINGE TO MAKE FLUID FLOW POSSIBLE. A VISUAL INSPECTION OF THE SAMPLES RECEIVED DID NOT IDENTIFY ANY PRODUCT DEFECTS OR MANUFACTURING ISSUES WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICES WITH A RETAINED 50ML BD PLASTIPAK SYRINGE; NO FLOW RESTRICTION OR OCCLUSION WAS OBSERVED THROUGHOUT TESTING. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202048 AND 202031 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO OCCLUSIONS WERE OBSERVED DURING TESTING. HOWEVER TESTING CONDUCTED DURING PREVIOUS INVESTIGATIONS HAS DEMONSTRATED THAT DEPENDING ON THE PRIMING TECHNIQUE AND THE CLINICAL USAGE OF THE PRODUCT, IT IS POSSIBLE FOR FLUID TO FLOW THROUGH THE AIR VENT AND "WET-OUT" THE FILTER, RESTRICTING THE OPPORTUNITY FOR AIR TO PASS BACK THROUGH THE MEMBRANE AND CAUSING AN OCCLUSION. IN THIS INSTANCE BASED ON THE INFORMATION AVAILABLE IT HAS NOT BEEN POSSIBLE TO CONFIRM WHETHER THIS MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 202031, MEDICAL DEVICE EXPIRATION DATE: 20-AUG-2023, DEVICE MANUFACTURE DATE: 02-MAR-2021. MEDICAL DEVICE LOT #: 202048, MEDICAL DEVICE EXPIRATION DATE: 03-DEC-2023, DEVICE MANUFACTURE DATE: 27-APR-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SINGLE VIAL ACCESS DEVICE VENTED WITH SS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT DUE TO BLOCKAGES. WHEN WE TESTED THESE DEVICES WE CONFIRMED THAT THEY WERE BLOCKED BUT THAT THE BLOCKAGE COULD BE CLEARED BY APPLYING SOME EXTRA PRESSURE ON THE SYRINGE PLUNGER AND AFTER THAT THE DEVICE FUNCTIONED NORMALLY. AS THE CUSTOMER IS PREPARING SMALL QUANTITIES OF EXPENSIVE SUBSTANCES IT IS NOT POSSIBLE FOR THEM TO CLEAR ANY BLOCKAGE BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SINGLE VIAL ACCESS DEVICE VENTED WITH SS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT DUE TO BLOCKAGES. WHEN WE TESTED THESE DEVICES WE CONFIRMED THAT THEY WERE BLOCKED BUT THAT THE BLOCKAGE COULD BE CLEARED BY APPLYING SOME EXTRA PRESSURE ON THE SYRINGE PLUNGER AND AFTER THAT THE DEVICE FUNCTIONED NORMALLY. AS THE CUSTOMER IS PREPARING SMALL QUANTITIES OF EXPENSIVE SUBSTANCES IT IS NOT POSSIBLE FOR THEM TO CLEAR ANY BLOCKAGE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665755 SINGLE VIAL ACCESS DEVICE VENTED WITH SS INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown