MAUDE Adverse Event Report: QUEST MEDICAL, INC. STENTUBE; LACRIMAL STENTS AND INTUBATION SETS

Catalog Number LIS052

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

When using the stentube lacrimal intubation set-large diameter, one of the tubes broke away from the inserter.Three tubes were on the field-two were used; the defective one removed.No harm to patient.

• Brand Name: STENTUBE
• Type of Device: LACRIMAL STENTS AND INTUBATION SETS
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown pkwy; allen TX 75002
• MDR Report Key: 3687367
• MDR Text Key: 15265590
• Report Number: 3687367
• Device Sequence Number: 1
• Product Code: HNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: LIS052
• Device Lot Number: 0448683S01 OR 0440663A09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 61 YR
• Patient Weight: 117