MAUDE Adverse Event Report: MEDLINE INDUSTRIES NAMIC STOPCOCK; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Catalog Number	70055009
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of atrial fibrillation.Procedure: electrophysiology study with ablation.3-way stopcock was leaking on the luer lock side, which could have introduced air.Tried to problem solve source and changed the iv tubing but it still was leaking air.The stopcock was changed and there was no further leaking.No known harm to the patient, minor delay in procedure.Manufacturer response for stopcock, namic (per site reporter), will obtain.

• Brand Name: NAMIC STOPCOCK
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline place; mundelein IL 60060
• MDR Report Key: 17571530
• Report Number: 17571530
• Device Sequence Number: 13001138
• Product Code: DTL
• UDI-Device Identifier: 10193489065695
• UDI-Public: (01)10193489065695(17)250321(10)0000040196
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/14/2023
• Report Date (Section F): 08/14/2023

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 Catalogue Number: 70055009
• Device Lot Number: 0000040196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 08/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 08/14/2023