MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE; 12-24 FR STANDARD G-TUBE

Model Number	70-0041-118
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Abdominal Pain (1685); Gastrointestinal Hemorrhage (4476)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The austrian federal office for safety in health care emailed, customer reported: after inserting the peg tube on (b)(6) 2024, the patient had pain and coagulated blood around the peg tube.In the ct abdomen, the peg probe was dislocated outside the stomach, the catheter tip was against the outer stomach wall, the balloon intact (5ml).Pat.Had to be acutely admitted to the operating room for (b)(6).Exportation with new installation of a gastric-tube, lot confirmed.
Additional Manufacturer Narrative
A1-a6) there was no patient information available from this event.D4) model number is xeridiem part number.Catalog number is part number of exclusive distributor cook medical.H3) the device was requested but confirmed that the device won't be delivered for investigation.Internal complaint number (b)(4).Device history record for lot 11050-01 was reviewed.Lot# 11050-01- manufacturing started on 5/06/2023.All line clearances, material verifications, and qc inspections were performed by trained spg (xeridiem) staff.The product was manufactured in accordance with the approved part specifications.2 ncrs were generated during the manufacturing of this lot but neither would contribute to this complaint.There were (b)(4) units scrapped during the manufacturing process.Multiple inspections are conducted throughout the process to identify defects and when these units were scrapped.There were no observations during the dhr review that would contribute to device malfunction.All operations were completed accordingly.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE
• Common Device Name: 12-24 FR STANDARD G-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: norman witteborg ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 7632279939
• MDR Report Key: 20866718
• Report Number: 2025851-2024-00010
• Device Sequence Number: 15626730
• Product Code: KNT
• UDI-Device Identifier: 00827002356177
• UDI-Public: (01)00827002356177(17)260605(10)11050C01
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K130611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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 Expiration Date: 06/05/2026
• Device Model Number: 70-0041-118
• Device Lot Number: 11050-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2023
• 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: Other; Required Intervention
• Patient Sex: Prefer Not To Disclose