BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE PENROSE DRAIN

    MDR report key: 15250417 · Received August 17, 2022

    Report

    Report Number
    MW5111567
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 16, 2022
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    NNZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DRAIN CUT TO 16 CM FOR USE AS RETRACTOR FOR HIATAL HERNIA REPAIR. DRAIN TORN AND 2CM PIECE BROKE AWAY. DISCOVERED DURING SURGERY AND REMOVED. DRAIN PIECES ALL PLACED TOGETHER AND FULL DRAIN ACCOUNTED FOR. MANAGEMENT NOTIFIED. DEFECTIVE PRODUCT FORM COMPLETE. DRAIN PLACED IN BIOHAZARD BAG FOR FURTHER EXAMINATION AND GIVEN TO MANAGEMENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494387 MEDLINE PENROSE DRAIN SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE NNZ MEDLINE INDUSTRIES, LP - NORTHFIELD DYND50428 59221122514

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female