BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENEMA BAG

    MDR report key: 2833127 · Received November 7, 2012

    Report

    Report Number
    9612030-2012-00055
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    July 12, 2012
    Report Date
    October 25, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FCE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED. COVIDIEN PRODUCT MONITORING CONTACTED THE CUSTOMER ON (B)(4) 2012 TO REQUEST ADD'L INFO. ON (B)(4) 2012, (B)(4) FROM THE RISK MANAGEMENT OFFICE COMMUNICATED THAT PER HOSPITAL'S POLICY, INFO REGARDING PT'S MEDICAL PROCEDURES IS CONSIDERED CONFIDENTIAL AND NO ADD'L INFO COULD BE PROVIDED. (B)(4) FURTHER STATED THAT PT'S CONDITION IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN ENEMA BAG. THE CUSTOMER REPORTS; THE PT REPORTED RECTAL FULLNESS AND BLOOD ON TOILET PAPER. AN ANEMA HAD BEEN ADMINISTERED EARLIER IN THE DAY. UPON EXAMINATION A BLUE, APPROX 5-INCH PLASTIC CAP FROM THE ENEMA BAG TUBING, WAS FOUND IN THE PT'S RECTUM. THE RN DID NOT REALIZE THE CAP SHOULD BE REMOVED. THERE IS NO LABELING ON THE CAP NOT TO INSERT INTO PT. THERE IS ALSO NOTHING IN THE PRODUCT LITERATURE TO ENSURE THE CAP IS REMOVED AND DISPOSED OF PRIOR TO INSERTION INTO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENEMA BAG ENEMA BAG FCE COVIDIEN 145540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other