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

Model Number	DCP213-BIT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest was notified about the alleged incident by the fda.Quest has contacted the user facility which filed teh report, to request additional information and return of the complaint sample for investigation.A follow up report will be submitted if additional information becomes available.
Event or Problem Description
The copy of the medwatch received from the fda states that there was a leak from the lacrimal duct catheter.A new set of catheter was used to complete the procedure.The alleged issue did not result in any patient complications.
Additional Manufacturer Narrative
The complaint samples were evaluated by inflating the device to determine the area of leak.The samples leaked at the luer connection.Close examination of the luer threads on the leaking samples indicated that there was hairline crack along the luer.A definitive root cause for the crack could not be established.The development of crack may be due to a combination of elevated external forces and molded in stress in the component or over tightening of the luer connection.The lacricath catheters undergo 100% inspection for leaks during assembly.The presence of cracks at the end of the luer would have been caught during manufacturing leak testing.In addition, the parts also undergo qc inspection for visual and functional test.The root cause of the crack resulting in the leak is unknown.Quest will continue to monitor trends.

• Brand Name: LACRICATH LACIMAL DUCT CATHETER
• Common Device Name: LACRIMAL DUCT CATHETER
• Manufacturer (Section D): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002
• MDR Report Key: 9447308
• Report Number: 1649914-2019-00070
• Device Sequence Number: 11429726
• Product Code: OKS
• UDI-Device Identifier: 10634624810188
• UDI-Public: 10634624810188
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K113867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: Health Professional
• Device Model Number: DCP213-BIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1