BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) KIT

    MDR report key: 2223427 · Received August 25, 2011

    Report

    Report Number
    9611594-2011-00098
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 9, 2011
    Report Date
    July 26, 2011
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOR THE IDENTIFIED PRODUCT LOT CONFIRMED THAT THE PRODUCT MET MANUFACTURING SPECIFICATIONS. ACCORDING TO THE REPORTING SITE, THE AFFECTED PRODUCT WAS DISCARDED FOLLOWING REMOVAL, SO IT WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS. THE REPORTING SITE RETURNED A SAMPLE CONSISTING OF AN UNOPENED PACKAGE OF A DEVICE FROM THE SAME PRODUCT LOT AS THE DEVICE INVOLVED IN THIS INCIDENT. THE UNUSED SAMPLE WAS EVALUATED BY VISUAL INSPECTION, DIMENSIONAL MEASUREMENTS, AND MEASUREMENT OF PEG TUBE RETENTION STRENGTH. RESULTS OF THESE EVALUATIONS IDENTIFIED NO DEVICE ANOMALY THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ROOT CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED WITHIN THE COMPLAINT AND MDR SYSTEMS. ONGOING ANALYSES OF COMPLAINT AND MDR TREND INFORMATION ARE USED TO IDENTIFY IF ADDITIONAL INVESTIGATIONS OR ACTIONS ARE WARRANTED. SAMPLE FROM THE SAME LOT NUMBER WAS RETURNED AND EVALUATED.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "PEG PLACEMENT: (B)(6), 2011 - AFTER A FUNDOPLICATION. BOWEL VERY SLOW. TREATMENT: ANTIBIOTIC: ERYTHROMYCIN AT PROKINETIC DOSIS (ERYTHROCIN) - STOMACH PROTECTION: RANITIDINE (ZANTAC) REPLACED BY OMEPRAZOLE (LOSEC) - AFTER PLACEMENT PAIN TREATMENT DURING 3 DAYS: KETOROLAC (TARADYL) AND TRAMADOL (CONTRAMAL). ECHOGRAPHY (CONTROL) ON (B)(6): NORMAL. (B)(6), BUMPER IS NOT VISUALIZED IN THE STOMACH, MIGRATED TO PERITONEUM. NO FEEDING ADMINISTERED, NO INFECTION. PEG TUBE WAS REMOVED AND A SURGICAL GASTROSTOMY WAS CREATED IN WHICH A MIC-KEY G-TUBE WAS PLACED." KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) KIT PEG KIT KNT KIMBERLY-CLARK HEALTH CARE AW021402

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention