MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT/1 20GA X 3"; ARTERIAL CATHETERS

Model Number	498106
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was returned for evaluation.A follow-up report will be submitted once a review of the sample has been completed.
Event or Problem Description
On 5/6/21, a female patient with initials hmc and date of birth 6/7/1950, (70 years old), had an argon arterial line placed.On 5, the art line quit recording.Upon removal, it was noted that a portion of the catheter was missing.Using the ultrasound machine, the resident saw the remaining portion of the catheter within the lumen of the radial artery.Vascular surgery states the patient is to unstable for operative intervention.As of today, the hand is stable with ulnar artery patent.Hand shows some improvement in discoloration of fingertips.
Additional Manufacturer Narrative
One catheter hub was returned for review.There was approximately 2 mm of the strain relief attached to the base of the hub.Based on the evaluation of the edges of the strain relief, it appears the strain relief was cut.The most probable cause for the detached tubing was due to an event within the user environment.Possibly a sharp instrument was utilized during the procedure that resulted in the separation of the tubing from the strain relief.
Event or Problem Description
On (b)(6) 2021, a female patient with initials hmc and date of birth (b)(6) 1950, (70 years old), had an argon arterial line placed.On (b)(6) 2021, the art line quit recording.Upon removal, it was noted that a portion of the catheter was missing.Using the ultrasound machine, the resident saw the remaining portion of the catheter within the lumen of the radial artery.Vascular surgery states the patient is to unstable for operative intervention.As of today, the hand is stable with ulnar artery patent.Hand shows some improvement in discoloration of fingertips.

• Brand Name: ARTERIAL LINE KIT/1 20GA X 3"
• Common Device Name: ARTERIAL CATHETERS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12054185
• Report Number: 0001625425-2021-01011
• Device Sequence Number: 19872347
• Product Code: GDY
• UDI-Device Identifier: 00886333215577
• UDI-Public: 00886333215577
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: 498106
• Device Catalogue Number: 498106
• Device Lot Number: 11359418
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other