BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE GASTROSTOMY TUBE, RIGHT ANGLE, WITH EN FIT CONNECTOR

    MDR report key: 23652293 · Received November 25, 2025

    Report

    Report Number
    2025851-2025-00013
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 25, 2025
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    UDI-DI
    00813939023770
    PMA / PMN Number
    K171347
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT NUMBER: (B)(4). THERE WERE TWO LOTS IDENTIFIED IN THE COMPLAINT DESCRIPTION: LOT: 11521-11 WITH EXPIRY DATE - 04-04-2027. LOT: 11490-09 WITH EXPIRY DATE - 02-23-2027. ROOT CAUSE SUMMARY: NO MANUFACTURING DEFECT WAS IDENTIFIED. THE FAILURE IS LIKELY DUE TO EXTERNAL MECHANICAL, CHEMICAL, OR ENVIRONMENTAL FACTORS BEYOND THE MANUFACTURER'S CONTROL. SAMPLE EVALUATION: DEVICES WERE NOT RETURNED FOR INVESTIGATION. PHOTOS DEPICTING COMPLAINT SYMPTOMS WERE PROVIDED BY THE CUSTOMER. THESE PHOTOS CONFIRM THE DEFECT; SOME OF THE DEVICES THAT WERE IN THE PHOTOS ARE NOT MANUFACTURED BY XERIDIEM.

    Description of Event or Problem · 0

    ECN EVENT DESCRIPTION: SITUACIÓN QUE NOS REPORTAN EN SURA DE LAS SONDAS DE RECAMBIO ENFIT, HAN TENIDO MÁS DE 5 PCTES, LOS CUALES HAN PRESENTADO SANGRADO PERIOSTOMAL DESDE EL CAMBIO DE LAS SONDAS, FILTRACIONES, DAÑO DEL ESTOMA Y PIEL PERILESIONAL, ESTO NO HABÍA OCURRIDO ANTES Y SE HA VENIDO EVIDENCIANDO DESDE LAS COLOCACIONES DE SEPTIEMBRE, AGRADEZCO CON LATAM SI PUEDES VALIDAR SI HAN PRESENTADO UNA SITUACIÓN SIMILAR. COMPARTO EVIDENCIAS FOTOGRÁFICAS DE LOS CASOS SITUATION REPORTED TO US AT SURA REGARDING ENFIT REPLACEMENT TUBES: THEY HAVE HAD MORE THAN 5 PATIENTS WHO HAVE PRESENTED PERISTOMAL BLEEDING SINCE THE TUBE CHANGE, LEAKS, DAMAGE TO THE STOMA AND PERILESIONAL SKIN. THIS HAD NOT OCCURRED BEFORE AND HAS BEEN EVIDENT SINCE THE SEPTEMBER PLACEMENTS. I WOULD APPRECIATE IT IF LATAM COULD VALIDATE WHETHER THEY HAVE PRESENTED A SIMILAR SITUATION. I SHARE PHOTOGRAPHIC EVIDENCE OF THE CASES WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT WHAT IS THE NEXT COURSE OF ACTION? VALORACIÓN POR ESPECIALISTA - SPECIALIST ASSESSMENT PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: DISCOMFORT / PAIN, EDEMA / INFLAMMATION / SWELLING, FLUID DISCHARGE, BURN(S) IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? UNKNOWN MEDICAL OR SURGICAL INTERVENTIONS: UNKNOWN PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN PATIENT OUTCOME: THE ISSUE IS ONGOING DEVICE ACQUIRED FROM A DISTRIBUTOR? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148272 ENDOVIVE GASTROSTOMY TUBE, RIGHT ANGLE, WITH EN FIT CONNECTOR ENDOVIVE G-TUBES WITH ENFIT CONNECTOR PIF XERIDIEM MEDICAL DEVICES 70-0053-222 11521-11, 11490-09 00813939023770

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other