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

Model Number LDC315T

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number of the affected product was not provided.Visual examination of the returned device confirmed a crack on the catheter hub.For functional testing, the sample was attached to the same syringe sent by the customer filled with water to simulate real time use.The catheter did leak at the hub.It is possible extra force has been applied or the luer could have cracked during manufacturing or by force applied by the user.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Event Description

The nurse reported an issue was encountered with the 3mm balloon catheter device during use.She reported that while the procedure was underway the staff observed that water was running out of the device.The report stated they removed the device and noticed a crack on the catheter hub.They opened another device and completed the procedure with no patient complications.The lot number was not provided.The device was returned to the manufacturer for evaluation.

• Brand Name: LACRICATH LACRIMAL DUCT CATHETER
• Type of Device: LACRIMAL STENTS AND INTUBATION SETS
• 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 ; 9723326338
• MDR Report Key: 5701804
• MDR Text Key: 47908955
• Report Number: 1649914-2016-00028
• Device Sequence Number: 1
• Product Code: OKS
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: LDC315T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention