BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBVIE PEG

    MDR report key: 4760247 · Received May 8, 2015

    Report

    Report Number
    3010757606-2015-00003
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    April 11, 2015
    Report Date
    April 12, 2015
    Manufacturer
    ABBVIE - MEDICAL DEVICE CENTER
    Product Code
    KNT
    PMA / PMN Number
    K142793
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ONE PEG-J TUBING RETURN SAMPLE WAS RECEIVED AT ABBVIE FOR EXAMINATION. THE PEG-TUBING WAS VISUALLY INSPECTED AND DID NOT SHOW ANY DEFECTS OR DAMAGE. THE RETURNED PEG TUBING WAS REVIEWED, AND NO NON-CONFORMANCES OR DEVIATIONS WERE IDENTIFIED. 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. THIS EVENT WILL BE MONITORED THROUGH INTERNAL TRENDING METRICS. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED AFTER DEVICE EVALUATION IS COMPLETE. THE CATALOG NUMBER PROVIDED IS THE DOMESTIC LIST NUMBER THAT IS COMPARABLE TO THE INTERNATIONAL LIST NUMBER IN THE "OTHER" FIELD. DEVICE WAS RECEIVED BY THE MANUFACTURER AND EVALUATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED ON A PATIENT IN (B)(6). THE PATIENT HAD A PEG AND INTESTINAL TUBE PLACED (B)(6) 2015. THE PATIENT REPORTED MILD ABDOMINAL PAIN LASTING FOR SEVERAL DAYS. THE PATIENT WAS ADMITTED TO HOSPITAL IN THE AFTERNOON OF (B)(6) 2015, AND SHE WAS DIAGNOSED WITH ABDOMINAL FLUID-FILLED CYST AFTER CT AND ABDOMINAL PARACENTESIS WERE PERFORMED. THE FLUID WAS PROGRESSIVELY DRAINED FROM THE CYST. THE PATIENT RECEIVES ORAL TREATMENT FOR PARKINSON'S DISEASE AND SHE IS STILL HOSPITALIZED. RADIOGRAPHIC SUSPICION OF PERFORATION WITHIN GASTROINTESTINAL TRACT, ALL ORAL MEDICATION WAS STOPPED. ON (B)(6) 2015 THE PEG/J TUBE WAS REMOVED, AFTER COMMAND OF THE GASTROENTEROLOGIST, DUE TO LEAKAGE OF MEDICATION IN THE PERITONEAL CAVITY LEFT AND DOWN TO THE DIAPHRAGM. THE GASTROSCOPY INDICATED A MILD IRRITATION ROUND THE PEG AND THE GASTROINTESTINAL TUBE WAS DISPLACED IN THE STOMACH AND IT WAS ALSO FOLDED IN A KINK. THERE WAS NO CONFIRMED PUNCTURE. POSSIBLE ROUTE OF DRUG TO THE PERITONEUM WAS THE PEG. THE SURGEON DECIDED TO PUT AN EXTERNAL PERITONEAL SHUNT AND WAIT IN ORDER TO AVOID AN OPEN SURGERY DUE TO THE AGE OF THE PATIENT. POSSIBLE MECHANISM OF COMPLICATION WAS SEVERE CONSTIPATION AND LABORIOUS EMPTYING AFTER USE ENEMA, 2-3 DAYS AFTER PEG PROCEDURE. THEREFORE, THE PEG WAS REMOVED. PERITONEAL DRAINAGE WAS REMOVED ALONG WITH THE PEG/J. THE PEG/J TUBE WILL PROBABLY BE REPLACED WITH ANOTHER ONE IN ONE MONTH. THE PATIENT WILL REMAIN IN THE HOSPITAL UNTIL SHE RECOVERS AND SHE WILL CONTINUE THE ORAL TREATMENT THAT SHE HAD BEEN GIVEN RIGHT AFTER THE PUMP WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303433 ABBVIE PEG KNT - GASTROINTESTINAL TUBE AND ACCESSORIES KNT ABBVIE - MEDICAL DEVICE CENTER 32294374

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O MADOPAR, LEVODOPA| BENSERAZIDE HYDHROCHLORIDE