MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES GASTROSTOMY TUBE - DUAL ENFIT PORT

Model Number 70-0062-220

Device Problem Migration (4003)

Patient Problem Abdominal Pain (1685)

Event Date 01/24/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not available.Model number is xeridiem part number for device; catalog number is part number for device's exclusive distributor vesco medical.Date is when user medwatch was received which changed reportability decision based on additional information.Returned device was visually inspected and functionally tested for retention bolser adjustment - no loose fit was found.Retained sample from same lot was similarly tested with no problems found and was also measured for bolster slip force which was in specification.Therefore, cause could not be confirmed.

Event Description

The device was in place for less than a month when it traveled into the patient's duodenum during normal daily routines.Caregiver indicated that patient is pretty immobile and moves from bed to wheelchair daily.She indicated the bumper is loose to past g-tubes they have used.User voluntary medwatch report mw5092795 was received and further indicated that patient presented to er with abdominal pain, unable to tolerate enteral feeding.Patient was without nutrition for 2 days at time of device removal.Device had passed into duodenum and was causing blockage.

• Brand Name: GASTROSTOMY TUBE - DUAL ENFIT PORT
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson, az
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson, az
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson, az ; 8827794178
• MDR Report Key: 9832248
• MDR Text Key: 189329894
• Report Number: 2025851-2020-00001
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 00813939024944
• UDI-Public: (01)00813939024944(17)220618(10)1002103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: 70-0062-220
• Device Catalogue Number: VED-220
• Device Lot Number: 1002103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention