BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLAMP, UMBILICAL CORD, PLASTIC

    MDR report key: 1943028 · Received December 22, 2010

    Report

    Report Number
    1417592-2010-00076
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    August 22, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN NO RESPONSE FROM THE ACCOUNT TO MULTIPLE MESSAGES LEFT. THE MEDWATCH REPORT INDICATED THAT THE BABY WAS HANDED OFF TO THE NURSE AT THE DELIVERY. THE NURSE NOTED THAT THE CORD WAS NOT CLAMPED AND WAS BLEEDING. THE NURSE IMMEDIATELY CLAMPED THE CORD WITH HER HAND UNTIL A CORD CLAMP WAS PLACED ON THE CORD. THE PHYSICIAN STATED THAT HE HAD CLAMPED THE CORD. THE CORD CLAMP WAS FOUND IN THE HAZARDOUS WASTE 'KICK BUCKET', SECURELY FASTENED. THE ACCOUNT DID NOT DETERMINE A CAUSE FOR THE INCIDENT . THE INFANT WAS OBSERVED IN NICU DUE TO BLOOD LOSS AND WAS TRANSFERRED TO THE GENERAL NURSERY POST TRANSITION. NO SAMPLE WAS RETURNED FOR EVAL. IT IS NOT KNOWN IF PHYSICIAN ERROR PLAYED A ROLE IN THIS INCIDENT OR IF THE DEVICE DID NOT FUNCTION AS INTENDED. (B)(4). NO TREND EXISTS FOR THIS ISSUE. WITHOUT A SAMPLE TO EVALUATE, NO ROOT CAUSE HAS BEEN DETERMINED. NO CORRECTIVE ACTION IS INDICATED AT THIS TIME. HOWEVER, DUE TO THE REPORTED INCIDENT, A MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE BABY WAS HANDED OFF TO THE NURSE, WHO NOTED THAT THE CORD WAS NOT CLAMPED AND WAS BLEEDING. THE NURSE IMMEDIATELY CLAMPED THE CORD. THE CLAMP WAS FOUND IN HAZARDOUS WASTE "KICK BUCKET" SECURELY FASTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP, UMBILICAL CORD, PLASTIC NONE FOD MEDLINE INDUSTRIES, INC. DYNJ04220 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA