MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE GASTROSTOMY TUBE WITH ENFIT CONNECTOR

Model Number 70-0051-218

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Infection (1930)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

A1-a6) only patient information available was the patient's age.D4) model number is xeridiem's part number; catalog number is exclusive distributor (boston scientific) part number which appears on the label.G3) mdr filed based on retrospective complaint review done in october 2023; this report is for xeidiem complaint number (b)(4).H3) device has not been evaluated because it has not been returned.Therefore, the allegation of bolster movement causing stoma infection cannot be confirmed.Nothing in reviewed production records for lot indicated any potential issue that could cause the alleged problem.H6) codes chosen based on reported information; since device was not returned and investigation did not find evidence of a bolster issue, the alleged problem could not be confirmed.

Event Description

The device has been used for artificial feeding.The device bolster which should avoid the continuous friction of the gastrotube within the stoma is ineffective because it does not keep the position.The rubbing of the tube caused a local stoma infection.Patient involved, age (b)(6).Devices involved: 5; this report is for one of the five devices.

• Brand Name: ENDOVIVE GASTROSTOMY TUBE WITH ENFIT CONNECTOR
• Type of Device: GASTROSTOMY TUBE
• 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: steve murray ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 5208827794
• MDR Report Key: 18297364
• MDR Text Key: 330088976
• Report Number: 2025851-2023-00006
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K171347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2023
• Device Model Number: 70-0051-218
• Device Catalogue Number: M00509911
• Device Lot Number: 10656-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR