BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICU MEDICAL

    MDR report key: 2388631 · Received December 19, 2011

    Report

    Report Number
    MW5023538
    Event Type
    Injury
    Date Received
    December 19, 2011
    Date of Event
    December 5, 2011
    Report Date
    December 19, 2011
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT IS A (B)(6). (B)(6). DIAGNOSIS: CHRONIC PYLORIC STENOSIS AND A PEG TUBE FOR DRAINAGE OF THE GASTRIC CAVITY IN NEED OF TPN CONTINUOUS OVER 24 HRS. HISTORY OF STAGE 4 PERITONEAL CA AND BREAST CA WITH WIDESPREAD METASTASIS. PT CALLED ON (B)(6) 2011 WITH PROBLEM WITH ANCILLARY SUPPLY. INJECTION CAP WITH ATTACHED EXTENSION SET: (B)(6): 12 INCH SMALLBORE EXT SET. MICROCLAVE, (B)(4), LOT#: 2338466, EXP: 09/2017. (B)(4) WAS LEAKING AT THE DISTAL END OF THE EXTENSION SET (FAR END AWAY FROM THE INJECTION CAP ATTACHMENT). LOOKED LIKE A BAD SEAL TO THE TUBING AND MALE SITE. HAD PT REMOVE THE INJECTION CAP/EXT SET IN QUESTION AND DID A DIRECT CONNECTION TO THE (B)(4) TUBING AND THERE WAS NO MORE LEAKING. DATES OF USE: (B)(6) 2011 - (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL 12 INCH EXT SET SMALLBORE WITH MICROCLAVE INJECTION FPA ICU MEDICAL 2338466

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability