BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDURA CATHETER

    MDR report key: 1040044 · Received May 7, 2008

    Report

    Report Number
    6000030-2008-02426
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 29, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THE PUMP REPLACED IN 2008 AND THE FOLLOWING DAY, THE PT EXPERIENCED ABDOMINAL SPASMS AND HYPERTONIA. THE NURSE WAS NOT SURE HOW MUCH OF A PRIMING BOLUS WAS PROGRAMMED AT THE REPLACEMENT TIME AND FELT IT WAS POSSIBLE THAT DRUG HAD NOT REACHED THE CATHETER TIP. THE HCP PERFORMED A SIDE PORT ASPIRATION OF THE PUMP AND FOUND NO FLOW. THE PT UNDERWENT A CATHETER REVISION AND IT WAS FOUND THE ONE OF THE STAY SUTURES CAUSED A CATHETER KINK BY THE TISSUE. FOLLOWING THE CATHETER REVISION PROCEDURE, THE PT'S SYMPTOMS RESOLVED AND THE PT RECOVERED WITHOUT SEQUELA. THE PT'S PUMP CONTAINED LIORESAL. REFERENCE MFR REPORT #2182207200802236.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA CATHETER LKK RICE CREEK MANUFACTURING 8709 J0177976R

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANTABLE INFUSION PUMP MODEL 8637| PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED:| EXPLANTED: