BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALE LL ADAPTOR

    MDR report key: 12022175 · Received June 17, 2021

    Report

    Report Number
    1911916-2021-00573
    Event Type
    Malfunction
    Date Received
    June 17, 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: SEVEN PHOTOS OF THE 1001-105-083 MODEL, LOTS 0004079243, 0004077536 AND 0004079244, WERE SHARED BY CUSTOMER. THE PHOTOS WERE INSPECTED AND DURING VISUAL INSPECTION THE CUSTOMER'S COMPLAINT OF A BROKEN LUER COULD BE CONFIRMED. FOUR OF THE PHOTOS WERE OF LOT 0004079244 AND SHOWED THE SURFACE OF THE BROKEN LUERS HAD A CLEAN CUT WITH FLASH ONLY IN BORDERS. NO PHYSICAL SAMPLES WERE RETURNED. THE PRODUCTS 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 0004079243 WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THE REPORTED ISSUE. THE COMPLETE LOT WAS MANUFACTURED, INSPECTED AND RELEASED ON 03-JUN-2019 PER VYAIRE'S INTERNAL PROCEDURES AND NO ISSUES WERE FOUND. THE DEVICE HISTORY RECORD FOR THE PART NUMBER: 1001-105-083 WITH LOT NUMBER 0004077536 WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THE REPORTED ISSUE. THE COMPLETE LOT WAS MANUFACTURED, INSPECTED AND RELEASED ON 11-MAR-2019 PER VYAIRE'S INTERNAL PROCEDURES AND NO ISSUES WERE FOUND. THE DEVICE HISTORY RECORD FOR THE PART NUMBER 1001-105-083 WITH LOT NUMBER 0004079244 WAS REVIEWED IN ORDER TO DETECT ANY ISSUE RELATED WITH THE REPORTED DEFECT DURING ITS MANUFACTURING. THE COMPLETE LOT WAS MANUFACTURED, INSPECTED AND RELEASED ON 05JUN2019 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.

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0004079243. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2019-06-14. MEDICAL DEVICE LOT #: 0004077536. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2019-03-25. MEDICAL DEVICE LOT #: 0004079244. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2019-06-14. 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
    911750 MALE LL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1