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

Model Number	70-0062-220
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson, az
• MDR Report Key: 9832248
• Report Number: 2025851-2020-00001
• Device Sequence Number: 11368101
• Product Code: PIF
• UDI-Device Identifier: 00813939024944
• UDI-Public: (01)00813939024944(17)220618(10)1002103
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention