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

Model Number 70-0060-112

Device Problem Material Rupture (1546)

Patient Problem Feeding Problem (1850)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

A1-a6) patient information details were not available.D4) model number is xeridiem part number; catalog number is exclusive distributor (cook medical) part number that appears on label.Lot number is unknown so expiration date is unknown.D9) customer complaint indicated device available for return but it has not yet been received as of this report filing.G3) original complaint received 6 oct 2023; updated information indicating reportability received 17 oct 2023.H3) device has not been evaluated because it has not yet been returned.

Event Description

The balloons of the entuit tube with enfit connection for internal fixation have been bursting frequently lately (three occurrences within a week).One patient received the feeding tube and the balloon burst a few weeks later, another patient had the same problem after 14 days and another patient presented again with a burst balloon on the same day he received the feeding tube.In all three cases, the tube had to be removed (and new one inserted) because it slipped out due to the lack of internal fixation.According to the initial reporter, the patient experience adverse effects due to this occurrence (specifically, hospital could not administer food and medication according to the treatment plan).This report is for one of the three cases (other two will be in separate mdrs).

Manufacturer Narrative

D9, h2) device was not returned for evaluation; this follow-up report provides final investigation codes in h6 along with a summary of the investigation.H6) updated investigation codes chosen based on following summary of the investigation: the device was not returned for evaluation so investigation was limited to reported information and part number trending (8 balloon burst complaints in product family for prior year).Because of this, root cause cannot be established.During manufacturing, each device is tested100% including a balloon inflation test.Factors that can affect device performance include device handling, packaging, shipping, storage, cleaning and maintenance.Additional possibilities that affect balloon life include unique patient factors such as diagnosis, treatment, surgical procedures, as well as medications, nutrition formulas, and gastric ph.Production personnel are trained and certified for manufacture of the devices.Trending of complaints for the device will continue to be monitored.

Event Description

Event description is in original mdr on 11/16/2023.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• 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: 18131793
• MDR Text Key: 328057638
• Report Number: 2025851-2023-00004
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0060-112
• Device Catalogue Number: SBRD-12-ENF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• 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): Required Intervention