MAUDE Adverse Event Report: QUEST MEDICAL, INC. LACRICATH LACRIMAL DUCT CATHETER

Model Number LDC315T

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

The surgical center materials manager reported an issue encountered with a lacrimal duct catheter during use.The report stated the device would not inflate.There were no patient complications reported as a result of the alleged issue.Another device was used to complete the procedure.The device was returned to the manufacturer for evaluation.

Manufacturer Narrative

The sample box was opened for evaluation and there was no device inside.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: LACRICATH LACRIMAL DUCT CATHETER
• Type of Device: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002
• MDR Report Key: 6713212
• MDR Text Key: 80247340
• Report Number: 1649914-2017-00057
• Device Sequence Number: 1
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/07/2020
• Device Model Number: LDC315T
• Device Lot Number: 0531747M06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention