MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION; Gastrointestinal Tubes with Enteral Specific Connectors

Model Number	70-0060-116
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device returned as of (b)(6)2025 therefore no sample evaluation cannot be conducted.If a sample returns this report will be re-opened and re assessed.Internal complaint number: #(b)(4).
Event or Problem Description
As per esoks translation: (b)(4) email from customer.Email from customer to (b)(4).Following a gastrostomy on (b)(6)2024, the medical staff observed bleeding at the orifice on the (b)(6)2025.Local care is then provided.03/12/2025 in the morning: discovery of a balloon deflated: the probe is removed allowing the observation of a porous balloon.Device is available for return.Date of incident: (b)(6)2025.Location of incident: resuscitation.Circumstances of incident / description of facts.Following a gastronomy on (b)(6)2024, we noticed bleeding around the opening on 02/01: the area was then treated.On the morning of (b)(6)2025: balloon found to be deflated: the tube was removed enabling us to see that the balloon was porous.Clinical consequences observed.No direct clinical consequences.Precautionary measures and actions taken: the laboratory has been informed and the device is being held at the pharmacy in case the laboratory wishes to analyse it.The customer confirmed the incident did take place on (b)(6)2025.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION
• Common Device Name: Gastrointestinal Tubes with Enteral Specific Connectors
• 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: norman witteborg ; 4700 s overland drive; tucson, AZ 85714-3430 ; 7632279939
• MDR Report Key: 21277716
• Report Number: 2025851-2025-00002
• Device Sequence Number: 7909019
• Product Code: PIF
• UDI-Device Identifier: 00827002447820
• UDI-Public: (01)00827002447820(17)261129(10)11250C007
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2025

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
• Device Model Number: 70-0060-116
• Device Lot Number: 11250-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Prefer Not To Disclose