MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT 20GA X 3"

Model Number	498411B
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
Arterial line was placed on (b)(6) 2022 the arterial patients line dressing was changed per protocol.After removing the pervious dressing, a strong arterial line reading was noted on the monitor and a new was applied.The arterial line was functioning properly for a few minutes after the dressing change as the arterial line tubing was removed and immediately it was recognized that the majority of the arterial line catheter had broken on and remained in the patient artery.The patient was subsequently taken to the or for removed to the retained portion of the arterial catheter.

• Brand Name: ARTERIAL LINE KIT 20GA X 3"
• Common Device Name: ARTERIAL LINE KIT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 13839834
• Report Number: 0001625425-2022-00964
• Device Sequence Number: 5562648
• Product Code: GDY
• UDI-Device Identifier: 00886333215652
• UDI-Public: 00886333215652
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K780871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/21/2022

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 Model Number: 498411B
• Device Catalogue Number: 498411B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-4/13/2020-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown