BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY CARE UNIT

    MDR report key: 51712 · Received November 21, 1996

    Report

    Report Number
    1043577-1996-00109
    Event Type
    Malfunction
    Date Received
    November 21, 1996
    Date of Event
    October 1, 1996
    Manufacturer
    ALLEGIANCE-SURGICAL GROUP
    Product Code
    LRR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A DELIVERY THE PHYSICIAN OBSERVED MECONIUM STAINING IN THE AMNIOTIC FLUID. THE PHYSICIAN TRIED TO SUCTION THE INFANT USING THE 10 FR SUCTION CATHETER CONTAINED IN THE KIT. THERE WAS SUCTION TO THE CATHETER BUT NO SUCTIONING FROM THE INFANT WAS OBSERVED. THE INFANT COULD HAVE ASPIRATED THIS FLUID AND CAUSED ASPIRATED PNEUMONIA. INFANT WAS TRANSFERRED TO THE NEONATAL ICU FOR OBSERVATION AND TOXICOLOGY TESTING. NO ADD'L TREATMENT WAS NECESSARY. INFANT OBSERVED FOR ONY 3-4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABY CARE UNIT BABY CARE UNIT LRR ALLEGIANCE-SURGICAL GROUP PL12BCYHB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention