MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT LP GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT; GASTROSTOMY TUBE

Model Number 70-0061-614

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/28/2019

Event Type  Death  

Manufacturer Narrative

Patient information was not available.Model number is xeridiem part number for the device.Catalog number is part number for cook medical, xeridiem's exclusive distributor for the device.Complete udi is not known since lot number is not known.Explant date based on death date.Initial reporter is distributor contact.Site was (b)(6) hospital in (b)(6).Manufacturer date is not known since lot number is not known.Codes based on initial complaint report since device was not returned.Physician stated that death was not related to the feeding tube.

Event Description

Patient had successful placement of the feeding tube on (b)(6) 2019.Hospital reported on (b)(6) 2019 that the patient had expired.It was explained that the patient had throat cancer and took a turn for the worse approximately a week after feeding tube placement.The patient was sent for fluoro to see if feeding tube was in stomach, and it was where it was supposed to be.No free air was showing.The physician said the patient death had nothing to do with the feeding tube, that everything was status quo, and had no issues with it.

• Brand Name: ENTUIT LP GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson,
• 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: 8828565
• MDR Text Key: 152300198
• Report Number: 2025851-2019-00005
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0061-614
• Device Catalogue Number: LP-SBRD-14-3.5-ENF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Death