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

Model Number	LIS052
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The facility's purchasing coordinator reported that when the physician was using the lacrimal intubation set, the tubing broke on 4 of them (same lot).There were no patient complications reported as a result of the alleged report.There was no additional information provided.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Four samples were returned for evaluation.Three had the probe still attached but one sample had both probes detached.The three intact samples successfully passed pull force testing.The reported complaint could not be duplicated.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: STENTUBE LACRIMAL INTUBATION SET
• Common Device Name: LACRIMAL INTUBATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6762653
• Report Number: 1649914-2017-00065
• Device Sequence Number: 2065332
• Product Code: OKS
• UDI-Device Identifier: 10634624815527
• UDI-Public: 10634624815527
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K113118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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
• Operator of Device: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: LIS052
• Device Lot Number: 0525116D02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention