BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LL ADAPTOR

    MDR report key: 12024411 · Received June 18, 2021

    Report

    Report Number
    2243072-2021-01708
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 21, 2021
    Report Date
    July 21, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS OF THE 1001-105-083 MODEL WERE SHARED BY CUSTOMER, ONE PHOTO OF LOT # 0001217504 AND TWO OF UNKNOWN LOTS. THE PHOTOS WERE INSPECTED AND DURING VISUAL INSPECTION, THE CUSTOMER'S COMPLAINT OF A BROKEN LUER COULD BE CONFIRMED. NO PHYSICAL SAMPLES WERE RETURNED. THE PRODUCT REPORTED WAS MANUFACTURED BY SUPPLIER (VYAIRE) AND MANUFACTURING INFORMATION WAS REQUESTED: THE DEVICE HISTORY RECORD FOR THE PART NUMBER 1001-105-083 WITH LOT NUMBER 0001217504 WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THIS CUSTOMER REPORT DURING ITS MANUFACTURING. THE COMPLETE LOT WAS MANUFACTURED, INSPECTED AND RELEASED ON 04APR18 PER VYAIRE'S INTERNAL PROCEDURES AND NO ISSUES WERE FOUND. THE MOLD WAS TRANSFERRED FROM VYAIRE TO THE NORTH AMERICAN MOLDING CENTER (NAMC) IN OCTOBER 2019, WHERE 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. NO IMMEDIATE ACTION WAS REQUIRED SINCE THE MOLD WAS RELOCATED TO SITE BD NAMC, HOWEVER, A NOTIFICATION OF THE COMPLAINT WAS SUBMITTED TO BD NAMC ON 10JUN2021. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MALE LL ADAPTOR BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE LUER WAS BROKEN AND RESULTED IN LEAKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0001217504. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2018-03-01. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MALE LL ADAPTOR BROKE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE LUER WAS BROKEN AND RESULTED IN LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919674 MALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1