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

Model Number 498411B

Device Problems Break (1069); Nonstandard Device (1420)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/27/2022

Event Type  malfunction  

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 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"
• Type of Device: 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
• MDR Text Key: 295899439
• Report Number: 0001625425-2022-00964
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 00886333215652
• UDI-Public: 00886333215652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780871
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• 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
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1625425-4/13/2020-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other