BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LL ADAPTOR

    MDR report key: 11838905 · Received May 17, 2021

    Report

    Report Number
    9616066-2021-51044
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    September 15, 2021
    Product Code
    FPA
    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

    INVESTIGATION: ONE PHOTO OF MODEL 1001-143-022, WAS RECEIVED BY THE CUSTOMER FOR INVESTIGATION. UPON VISUAL INSPECTION, A CRACK ON THE LUER WAS OBSERVED. THE CUSTOMER'S COMPLAINT THAT THE DEVICE IS CRACKED WAS VERIFIED. NO PHYSICAL SAMPLES WERE AVAILABLE FOR INSPECTION SINCE THE CUSTOMER SENT THE SAMPLES TO THE WRONG LOCATION AND COULD NOT BE LOCATED. THE PRODUCT REPORTED WAS MANUFACTURED BY SUPPLIER (VYAIRE) AND MANUFACTURING INFORMATION WAS REQUESTED. THE SUPPLIER CONDUCTED A DHR REVIEW, AND NO ISSUES WERE FOUND DURING THE MANUFACTURING OF THE REPORTED LOT. THE PRODUCT WAS MANUFACTURED ACCORDING TO INTERNAL PROCEDURE. THE MOLD WAS TRANSFERRED FROM VYAIRE TO THE NORTH AMERICAN MOLDING CENTER (NAMC) ON OCTOBER 2019. IT WAS DISASSEMBLED, INSPECTED AND CLEANED. THESE INSPECTIONS AND IF NECESSARY, CORRECTIONS ARE DONE TO ALL VYAIRE TRANSFER MOLD RECEIVED AT THE NAMC BEFORE THE MOLD RUNS. SINCE THE MOLD WAS TRANSFERRED AND NO ISSUES WERE FOUND DURING MANUFACTURING, THE ROOT CAUSE COULD NOT BE DETERMINED. THE INSPECTION AND CONTROL PROCESSES AT NAMC ARE DESIGNED DETECT, CONTAIN AND PREVENT RELEASE OF THIS AND ALL DEFINED DEFECTS. THE SPECIFIC DEFECT (CRACK) WAS NOT PRESENT IN THE OQ OR PQ QUALIFICATION RUNS FOR THE TOOL THAT IS USED TO MANUFACTURE THIS PART CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MALE LL ADAPTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR MANUFACTURING DEPARTMENT INFORMED ME THAT DEFECTIVE THE PRODUCT (1001-143-022). IT SEEMS THERE IS A CRACK."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 · 1

    IT WAS REPORTED THAT THE MALE LL ADAPTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR MANUFACTURING DEPARTMENT INFORMED ME THAT DEFECTIVE THE PRODUCT (1001-143-022). IT SEEMS THERE IS A CRACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727850 MALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA 0001080327

    Patients

    Seq Age Sex Outcome Treatment
    1