MAUDE Adverse Event Report: JOIMAX, INC. VERSICON; LAVAGE, JET

Model Number JTSB350D

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/07/2015

Event Type  malfunction  

Event Description

The tubing for joimax leaked.The tubing was removed from field, discarded, and replaced with new tubing.No further issues.

• Brand Name: VERSICON
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): JOIMAX, INC.; 733 bolsana dr; laguna CA 92651
• MDR Report Key: 5334292
• MDR Text Key: 34651538
• Report Number: 5334292
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2015

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
• Device Operator: No Information
• Device Expiration Date: 05/30/2020
• Device Model Number: JTSB350D
• Device Lot Number: 04.05.2015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR