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

Model Number	70-0041-114
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Balloon failed, was inserted 2 days prior, device fell out of patient.Patient was admitted to emergency room at hospital.
Additional Manufacturer Narrative
A1-a6) no patient information was available for this incident.D4) model number is xeridiem part number; catalog number is part number of exclusive distributor cook medical that appears on the label.H3) device has not yet been evaluated because it has not been received by xeridiem as of this filing.H6) codes chosen based on information provided in the complaint and investigation still being in process.
Additional Manufacturer Narrative
D9) device was not returned for evaluation.H6) updated investigation codes in h6 were chosen based on the following investigation summary: no device has been returned so no evaluation of the involved device could be performed.Therefore, a root cause for the reported problem could not be determined.The production lot record for lot number 11224c002 was reviewed.While there units scrapped during the manufacturing process, none were for issues that would be related to the reported problem.Complaint records for the previous year ((b)(6) 2023 - (b)(6) 2024) were reviewed.For the (b)(4) device family, there were (b)(4) other complaints for the leak/deflate code with (b)(4) of those complaints being for (b)(4) specifically.Xeridiem's final (b)(4) complaint report notes that these devices are 100% tested throughout multiple stages of the manufacturing process, including a 100% balloon inflation test for a minimum 10-minute duration prior to accepting the unit for distribution.Additional manufacturing controls include certification of production personnel for manufacturing the device, line clearances, cleanroom maintenance at correct operating parameters, and qc functional device inspection prior to distribution.Xeridiem will continue to monitor complaint trends on the (b)(4) device family.
Event or Problem Description
Event description is in original mdr filed on (b)(6) 2024.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE
• 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: 19626495
• Report Number: 2025851-2024-00007
• Device Sequence Number: 15083148
• Product Code: KNT
• UDI-Device Identifier: 00827002356153
• UDI-Public: (01)00827002356153(17)261215(10)11224C002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70-0041-114
• Device Catalogue Number: SBRD-14
• Device Lot Number: 11224C002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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
• Patient Sex: Unknown