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

Model Number LIS27T

Device Problem Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned for evaluation.A dhr review could not be completed as the device lot number was provided by the customer.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 the silicone tubing detached from the probe.

• Brand Name: CRAWFORD LACRIMAL INTUBATION SET
• Type of Device: LACRIMAL INTUBATION SET
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• Manufacturer (Section G): EAGLE LABS; 10201-a trademark st; rancho cucamonga CA 91730
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 9413620
• MDR Text Key: 190527248
• Report Number: 1649914-2019-00066
• Device Sequence Number: 1
• Product Code: OKS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/04/2019

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
• Device Operator: No Information
• Device Model Number: LIS27T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1