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

Model Number 70-0041-116

Device Problem Material Rupture (1546)

Event Date 07/06/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 330667215
• Report Number: 2025851-2023-00011
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00827002356160
• UDI-Public: (01)00827002356160(17)260215(10)10973C001
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K130611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0041-116
• Device Catalogue Number: SBRD-16
• Device Lot Number: 10973C001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female