MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE 3S LOW PROFILE BALLOON KIT; LOW PROFILE BALLOON GASTROSTOMY TUBE

Model Number 70-0050-314

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Feeding Problem (1850)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Not all requested patient information was available.(b)(4) part number is 70-0050-314; (b)(4) (exclusive distributor) part number is m00548360; the (b)(4) part number is the one appearing on the device label.(b)(4) is legal manufacturer for the device and (b)(4) is our exclusive distributor.Therefore the initial reporter to (b)(4) is a person associated with (b)(4).The device was not available for evaluation.However, a capa investigation is in process for a trend in valve leakage.This invistigation is in process but appears to be pointing towards a design issue with the reflux valve (dome valve).A recall on the 70-0050-xxx devices was initiated on 12/23/2015.The removal report is planned to be submitted to fda as manufacturer removal report (b)(4).Device was not available for evaluation.

Event Description

The caregiver stated that every time she goes to disconnect the extension set after giving a bolus feed to her son that food contents are being refluxed out of the tube and leaks back out on her son.Procedural outcome: the caregiver has a backup balloon and placed it this afternoon.Patient status there is a little irritation at the stoma site from the food refluxing back on the patient.This is the second time this has happened to this patient.

• Brand Name: ENDOVIVE 3S LOW PROFILE BALLOON KIT
• Type of Device: LOW PROFILE BALLOON 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: 5352062
• MDR Text Key: 35313615
• Report Number: 2025851-2016-00003
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 08714729884293
• UDI-Public: (01)08714729884293(17)170504(10)920607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2017
• Device Model Number: 70-0050-314
• Device Catalogue Number: M00548360
• Device Lot Number: 920607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/07/2016
• 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 Age: 12 MO