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

Model Number	70-0041-116
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pneumoperitoneum (4819)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient gender was only information available.D4) model number is xeridiem part number; catalog number is exclusive distributor (cook) part number which appears on the label.G3) mdr filed based on retrospective complaint review done in october 2023.H3) no sample available (device not returned); therefore, no evaluation was able to be completed.H6) codes chosen based on reported information and limited complaint investigation possible; reported issue could not be confirmed.
Event or Problem Description
G-tube insertion and balloon didn't inflate.Patient had a contrast allergy so had to perform without contrast, which caused a lot of pneumoperitonea in the patient.Additional comments: no sample was available for investigation.

• 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: 18341298
• Report Number: 2025851-2023-00011
• Device Sequence Number: 20954675
• Product Code: KNT
• UDI-Device Identifier: 00827002356160
• UDI-Public: (01)00827002356160(17)260215(10)10973C001
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2023

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: 02/15/2026
• Device Model Number: 70-0041-116
• Device Catalogue Number: SBRD-16
• Device Lot Number: 10973C001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: Life Threatening
• Patient Sex: Female