BEUDAMED
    FDA Adverse Event Summary report: N

    NEONATAL BLOOD COLLECTION KIT AND SCREENING FORM

    MDR report key: 7037466 · Received November 15, 2017

    Report

    Report Number
    MW5073369
    Date Received
    November 15, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 13, 2017
    Manufacturer
    AMERICORD
    Product Code
    OIA
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FETAL CORD BLOOD COLLECTION KIT (AMERICORD) HAS INCORRECT PACKAGING FOR USE DURING SURGERY (CESAREAN SECTION). IF PRODUCT IS USED AS DIRECTED, YOU ARE PULLING A STERILE CORD BLOOD COLLECTION BAG THROUGH A TORN (NON-STERILE) OPENING, WHICH MAKES IT VIRTUALLY IMPOSSIBLE TO MAINTAIN STERILITY WHEN PASSING ONTO THE STERILE FIELD. MOTHERS ARE BEING PUT AT RISK OF A SURGICAL SITE INFECTION IF THIS PRODUCT IS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814566 NEONATAL BLOOD COLLECTION KIT AND SCREENING FORM BLOOD COLLECTION KIT OIA AMERICORD

    Patients

    Seq Age Sex Outcome Treatment
    1