BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT DRAIN 100CC W/7MM PERF

    MDR report key: 16942850 · Received May 16, 2023

    Report

    Report Number
    1423537-2023-00937
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 16, 2023
    Manufacturer
    PR006 PUERTO RICO-ANASCO
    Product Code
    GCY
    UDI-DI
    10192253022537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INDICATES THAT THE LOT NUMBER IS UNKNOWN, ALTHOUGH THE CUSTOMER HAS TWO LOT NUMBERS 1200283 AND 1200569 ON THE SHELF. THEREFORE, THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE TWO LOT NUMBERS. THESE LOT NUMBERS SHOWED THE PRODUCT WAS INSPECTED AND RELEASED IN COMPLIANCE WITH ALL REQUIREMENTS. THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, AN EVALUATION OF THE COMPLAINT DEVICE FOR DEFICIENCY OF CONSTRUCTION COULD NOT BE PERFORMED AND THE ROOT CAUSE REMAINS UNKNOWN. ALTHOUGH NO SAMPLE WAS RECEIVED, INSTRUCTIONS FOR USE EVALUATION WAS PERFORMED TO CONFIRM THAT THE REQUIRED STEPS TO AVOID BREAKAGE OF THE DRAIN ARE AVAILABLE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE SPINE SURGEON TRIED TO PLACE A JP DRAIN AND WHEN HE GRABBED THE END TO PULL IT THROUGH THE INCISION, THE PLASTIC LITERALLY CRUMBLED. PIECE WAS RETRIEVED WITH NO ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380986 KIT DRAIN 100CC W/7MM PERF APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY PR006 PUERTO RICO-ANASCO SU130-1360 UNKNOWN 10192253022537

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female