BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 5563949 · Received April 8, 2016

    Report

    Report Number
    3010757606-2016-00075
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 15, 2016
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE RECORD (B)(4). THE DEVICE MANUFACTURER AND LOT NUMBER OF THE PEG TUBE INVOLVED IN THIS EVENT WAS NOT PROVIDED BY THE COMPLAINANT. THEREFORE, IT IS UNKNOWN IF THE TUBING INVOLVED WAS THE ABBVIE PEG TUBE. CONSERVATIVELY, ABBVIE HAS CHOSEN TO REPORT THIS EVENT DUE TO THE POTENTIAL THAT THE PEG TUBE INVOLVED COULD HAVE BEEN THE ABBVIE PEG TUBE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, A BATCH RECORD REVIEW COULD NOT BE CONDUCTED. A RETURN SAMPLE EVALUATION WAS NOT PERFORMED BECAUSE TUBING WAS NOT RETURNED. THE INSTRUCTION FOR USE INDICATE TO SECURE PEG TUBE, PULL ON THE ABBVIE PEG TUBE UNTIL ELASTIC RESISTANCE IS FELT AND KEEP UNDER TENSION AND ABBVIE PEG TUBE SHOULD REMAIN UNDER MODERATE TENSION TOR 24-72 HOURS TO PROMOTE GOOD ADHERENCE OF THE STOMACH WALL TO THE INNER ABDOMINAL WALL. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MANUFACTURER WAS IDENTIFIED AS ABBVIE INC. 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.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) UNDERWENT PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL DUE TO PERITONITIS. THE CT SCAN OF ABDOMEN INDICATED PRESENCE OF FREE AIR IN ABDOMEN AND THERE WAS NO SIGNS OF PERFORATION. AT THE TIME OF ARRIVAL TO THE HOSPITAL, THE OUTER RETENTION PLATE OF THE PEG WAS FOUND TO BE LOOSE AND NOT CORRECTLY FIXED. AT 21:00 HOURS, THE PATIENT WAS SCHEDULED FOR AN OPERATION, WHICH WAS NOT PERFORMED FOR UNKNOWN REASONS. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR UNKNOWN REASON.

    Description of Event or Problem · 1

    FINAL DIAGNOSIS WAS PERITONITIS IN THE UPPER ABDOMEN. THE PEG TUBE WAS SLIGHTLY LOOSENED. A MIDLINE LAPAROTOMY, LAVAGE, OVERSEWING AT ENTRY POINT OF THE PEG AND GASTROPEXY WERE PERFORMED. THE OUTCOME WAS REPORTED TO BE PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217552 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32085225

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention