BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 5651505 · Received May 12, 2016

    Report

    Report Number
    3010757606-2016-00099
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 18, 2016
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). A BATCH RECORD REVIEW WAS PERFORMED FOR THE LOT NUMBER PROVIDED. ALL PARAMETERS WERE WITHIN SPECIFICATIONS INCLUDING STERILIZATION CRITERIA. NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. THE BATCH RECORD REVIEW DID NOT IDENTIFY ANY PROBABLE OR ROOT CAUSES THAT WOULD CONTRIBUTE TO THE PATIENT'S CONDITION. THE ABBVIE TUBING IS PERFORMING AS EXPECTED. NO CONFIRMED TRENDS WERE IDENTIFIED. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING WAS NOT AVAILABLE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG NUMBER 062941-001 IS THE INTERNATIONAL LIST NUMBER WHICH MEETS THE REQUIREMENTS OF THE SIMILAR PRODUCT LISTED IN MODEL AND LOT# WHICH IS THE US LIST NUMBER. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED; THEREFORE A RETURN SAMPLE EVALUATION WILL NOT BE PERFORMED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE BATCH RECORD REVIEW OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED. STOMATITIS IS A KNOWN COMPLICATION OF A PEG TUBE PLACEMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A PATIENT IN (B)(6) HAD A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACED. ON (B)(6) 2016, THE PATIENT REPORTED THAT THE PEG TUBE SITE WAS RED. THE PATIENT WAS SEEN BY THE PHYSICIAN IN THE AFTERNOON AND COMMENCED ON ANTIBIOTICS FLUCLOXACILLIN 500MG QDS AND CALVAPEN 666MG QDS FOR ONE WEEK. THE PATIENT WAS ADVISED TO INCREASE CLEANING OF SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305335 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32265205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention