MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARGO TRANS; TRANSDUCER ARTERIAL LINE WITH STOPCOCK

Model Number	2/MICRO/3ML 6'LINE, 9" EXT, STOPCOCK
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Atrial Flutter (1730); Pneumothorax (2012); Chronic Obstructive Pulmonary Disease (COPD) (2237)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Left radial arterial line in place drawing blood from the proximal port.Leaking began from backside of the three way stop cock when blood was pulled into the syringe.Blood flowed slowly then very quickly from the backside.It appeared a small white plug was missing or a mfr error with device.

• Brand Name: ARGO TRANS
• Common Device Name: TRANSDUCER ARTERIAL LINE WITH STOPCOCK
• Manufacturer (Section D): ARGON MEDICAL DEVICES; athens TX
• MDR Report Key: 8957205
• Report Number: 8957205
• Device Sequence Number: 19450502
• Product Code: DRS
• UDI-Device Identifier: 00886333201754
• UDI-Public: (01)00886333201754(17)220202(10)11171377
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 08/14/2019
• Report Date (Section F): 08/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2022
• Device Model Number: 2/MICRO/3ML 6'LINE, 9" EXT, STOPCOCK
• Device Lot Number: 11171377
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/14/2019
• Date Report to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 45
• Date Report Sent to FDA: 08/29/2019