MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE GASTROSTOMY TUBE, RIGHT ANGLE, WITH EN FIT CONNECTOR; ENDOVIVE G-TUBES WITH ENFIT CONNECTOR

Model Number	70-0053-222
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Abdominal Pain (1685); Burn(s) (1757); Inflammation (1932); Discomfort (2330); Gastrointestinal Hemorrhage (4476); Swelling/ Edema (4577)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint number: (b)(4).There were two lots identified from 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.
Event or Problem Description
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 (b)(6) 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.

• Brand Name: ENDOVIVE GASTROSTOMY TUBE, RIGHT ANGLE, WITH EN FIT CONNECTOR
• Common Device Name: ENDOVIVE G-TUBES WITH ENFIT CONNECTOR
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s overland drive; tucson AZ 85714 3430
• Manufacturer Contact: adin potter ; 4700 s overland drive; tucson, AZ 85714-3430 ; 5187414207
• MDR Report Key: 23652291
• Report Number: 2025851-2025-00012
• Device Sequence Number: 20026299
• Product Code: PIF
• UDI-Device Identifier: 00813939023770
• UDI-Public: (01)00813939023770(17)270223(10)1149009
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 70-0053-222
• Device Catalogue Number: M00510011
• Device Lot Number: 11521-11, 11490-09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown