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

Model Number 70-0041-224

Device Problem Deflation Problem (1149)

Patient Problem Feeding Problem (1850)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information is available.Model number is xeridiem part number.Catalog number is part number for cook medical, xeridiem's exclusive distributor for the device.Since lot number is unknown, full udi not available.Initial reporter is distributor contact (hospital site is in (b)(6)).Device was not returned for evaluation.Although definite cause cannot be established, it is noted from complaint report that balloon was inflated with other (contrast 50% dilution) than just distilled or sterile water (latter is directed in instructions for use).

Event Description

When doctor tried to take out gastrostomy catheter, it was not possible to deflate it through the valve, so it was needed to cut the catheter to take it out.Contents of balloon able to be removed with syringe but too slowly.No visible damage to balloon or valve.Outcome: procedural difficulties, longer for patient.

• Brand Name: ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY 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: 8340710
• MDR Text Key: 136262968
• Report Number: 2025851-2019-00001
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0041-224
• Device Catalogue Number: SBRD-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1