BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE 6 INCH EXT VLV

    MDR report key: 11336203 · Received February 16, 2021

    Report

    Report Number
    9616066-2021-50233
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 21, 2021
    Report Date
    March 16, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203011952
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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: 3/2/2021. H6. INVESTIGATION: ONE 20039E SAMPLE WAS RECEIVED FOR INVESTIGATION WITH THE PROTECTIVE CAP IN PLACE; NO PACKAGING WAS RECEIVED WITH THE SAMPLE, HOWEVER THE CUSTOMER INDICATES THE AFFECTED LOT NUMBER TO BE 20045709. ADDITIONALLY A PERFECT GRAVITY SET FROM LOT 202097 B02 WAS RECEIVED IN SEALED PACKAGING TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF THE 20039E SAMPLE DID NOT IDENTIFY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A VISUAL INSPECTION OF THE MALE LUER FROM THE PERFECT GRAVITY SET RECEIVED CONFIRMED IT TO BE A LUER SLIP; NO FLASH OR RAISED EDGES WERE IDENTIFIED ON THE TIP OF THE MALE LUER. MEASUREMENT OF THE TAPER CONFIRMED THE LUER SLIP WAS COMPLIANT WITH THE RELEVANT STANDARD. TESTING WAS PERFORMED BY CONNECTING THE LUERSLIP FROM THE GRAVITY SET TO THE 20039E SAMPLE AND PRIMING WITH FLUID; NO OCCLUSION WAS IDENTIFIED HOWEVER THE FLOW RATE WAS REDUCED DUE TO THE SMALLER TUBING BORE OF THE 20039E PRODUCT. ADDITIONALLY, THE SAMPLE WAS SUBJECTED TO FUNCTIONAL TESTING BY CONNECTING IT TO A 50ML BD PLASTIPAK SYRINGE FROM STOCK AND FLUSHING WITH FLUID; NO OCCLUSION OR FLOW RESTRICTION WAS IDENTIFIED DURING TESTING. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20045709 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE. TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN¿T PRIME EASILY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN¿T PRIME EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230821 SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20045709 07613203011952

    Patients

    Seq Age Sex Outcome Treatment
    1