MAUDE Adverse Event Report: GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC. JONES TUBE; PROBE, LACHRYMA

Model Number 3005489143

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

While placing a 4 x 16 jones tube during a bilateral dacryocystorhinostomy jones tubes conjunctivorhinostomy placement tube had broken and a piece of the jones tube (glass) thought to be in or around the patient.Fda safety report id# (b)(4).

• Brand Name: JONES TUBE
• Type of Device: PROBE, LACHRYMA
• Manufacturer (Section D): GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC. ; hillsboro OR 97124
• MDR Report Key: 10250065
• MDR Text Key: 198340510
• Report Number: MW5095429
• Device Sequence Number: 1
• Product Code: HNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/06/2020

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: 3005489143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1