BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR [PACK] VASCULAR OR PACK

    MDR report key: 13514311 · Received February 10, 2022

    Report

    Report Number
    MW5107390
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 8, 2022
    Manufacturer
    MEDLINE INDUSTRIES / MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MEDLINE VASCULAR PACK ONLY HAD 4 OF THE 5 SPONGES IN THE PACK. THIS IS CRITICAL WHEN ACCOUNTING FOR ALL SPONGES AT THE CONCLUSION OF A SURGICAL CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119136 VASCULAR [PACK] VASCULAR OR PACK CARDIOVASCULAR PROCEDURE KIT OEZ MEDLINE INDUSTRIES / MEDLINE INDUSTRIES, LP - SPT DYNJ49366 21LBC431

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male