MAUDE Adverse Event Report: QUEST MEDICAL, INC STENTUBE LACRIMAL INTUBATION SET

Lot Number 0528537J08

Device Problems Detachment Of Device Component (1104); Defective Component (2292); Cut In Material (2454); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device is being evaluated.A follow medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered during use of the lacrimal intubation set.The report states that he surgeon was unable to use the stent due to defective traits.Specific details were not give.Upon receipt of the complaint samples, the probe was found to have detached from the tubing.There were no reported patient complications resulting from the alleged issue.

Manufacturer Narrative

Two complaint samples were received and evaluated.Evaluation of the first sample showed detachment of the probe from one end of the silicone tube and a tear on the other end of the tube.Evaluation of the second sample showed detachment of one probe, while the other probe was still attached.Pull force testing was performed on the attached probe and the maximum pull force recorded was 1.15lb which is greater than the pull force specification of >1.0lbs, per internal inspection procedure which requires pull force check during the manufacturing process.A dhr review was conducted on the lot complained about and no anomalies were identified.The root cause of issue is not manufacturing related and is unknown.

• Brand Name: STENTUBE LACRIMAL INTUBATION SET
• Type of Device: LACRIMAL INTUBATION SET
• 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: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7268599
• MDR Text Key: 100270207
• Report Number: 1649914-2018-00020
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 0528537J08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1