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

Model Number 70-0041-116

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated date of event (only month provided in received user report 3600510000-2019-8015).Date original complaint received which was considered non-reportable by xeiridiem; user medwatch listed above was received from fda on june 3, 2019.This report is filed in response.Model number is xeridiem part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, cook medical.Lot number and complete udi is unknown.Manufacture date is unknown since no lot number was provided.During evaluation, no visual defects were found.The balloon was able to be inflated and retain inflation fluid without evidence of leakage.Therefore, the reported issue could not be confirmed.

Event Description

Peg tube came out of patient one day after being placed.Interventional radiology (ir) suspected product failure in regards to the balloon.Site covered with gauze.No active bleeding or discharge noted.

• 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 ; 5208827795
• MDR Report Key: 8669085
• MDR Text Key: 148414734
• Report Number: 2025851-2019-00003
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0041-116
• Device Catalogue Number: SBRD-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 78