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

Model Number	70-0060-118
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumoperitoneum (4819)
Date of Event	03/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4) model number is xeridiem part number; catalog number is part number of exclusive distributor cook medical that appears on the label.Device was not returned to xeridiem for evaluation.Choice of codes based on the following summary of the investigation: the device was not returned to xeridiem for evaluation.However, information from the user medwatch indicates that the rn administered iv fluid bolus through the balloon inflation port, causing the balloon to burst.This is an improper use of the device.The three ports of the device are clearly labeled med, feed and 5-10ml.The "5-10ml" is the recommended inflation fill volume for the balloon, thus indicating the purpose of that particular port (particularly in contrast to the labeling of the other two ports).The ifu indicates recommended inflation fill volume is printed on the device.In addition, review of the production lot's records did not show any issues for balloons during device manufacturing and testing.Xeridiem will continue monitoring for trends.
Event or Problem Description
Reported via user facility medwatch (b)(4): rn (registered nurse) inadvertently administered a fluid bolus through the balloon port of the g-tube causing the balloon to rupture.The patient complained of pain and felt a "pop" sensation.A stat ct confirmed a balloon rupture and pneumoperitoneum.The patient was taken emergently to the or (operating room) for exploratory laprotomy, gastric wedge resection, and gastrojejunostomy tube placement.There are 3 ports on the device, 1 is labeled "5-10ml" (not clearly labeled as balloon port), one is labeled "med" and one is labeled "feed".The order for the bolus was entered as an iv order so the nurse used an iv bag of ns (normal saline) and iv tubing which was able to be attached to the balloon port.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• Common Device Name: 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: 19492642
• Report Number: 2025851-2024-00005
• Device Sequence Number: 8558811
• Product Code: PIF
• UDI-Device Identifier: 00827002447837
• UDI-Public: (01)00827002447837(17)261129(10)11250C013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 70-0060-118
• Device Catalogue Number: SBRD-18-ENF
• Device Lot Number: 11250C013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 59 KG