MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL CATHETER MINI-KIT 20GA X 6"; ARTERIAL CATHETER MINI KIT

Model Number 498101

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

Following cardiac surgery, a patient presented to the icu with the named product placed in her left radial artery, which had been instilled 4 hours earlier.Lab personnel accessed the line to draw post op labs, then noted to the room nurse that there was some bleeding from the line dressing, the room nurse investigated and attempted to manipulate the line to stop further bleeding.When this did not work, the nurse attempted to remove the dressing to visualize the issue, when the dressing was removed, the hub of the arterial line came away from the insertion site, but the catheter remained in the patients radial artery, the icu providers were immediately notified to the issue, t he catheter was not visible but it could be palpated under the skin and visualized with ultrasound, the patient had to have an additional procedure with hand surgery to remove the catheter.

Event Description

Following cardiac surgery, a patient presented to the icu with the named product placed in her left radial artery, which had been instilled 4 hours earlier.Lab personnel accessed the line to draw post op labs, then noted to the room nurse that there was some bleeding from the line dressing, the room nurse investigated and attempted to manipulate the line to stop further bleeding.When this did not work, the nurse attempted to remove the dressing to visualize the issue, when the dressing was removed, the hub of the arterial line came away from the insertion site, but the catheter remained in the patients radial artery, the icu providers were immediately notified to the issue, t he catheter was not visible but it could be palpated under the skin and visualized with ultrasound, the patient had to have an additional procedure with hand surgery to remove the catheter.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One sample was returned for review.Visual inspection confirmed signs of use with the presence of dried bodily fluids.The arterial catheter hub was observed to be attached to the luer of the line.The strain relief was still attached to the hub of the catheter.The detached catheter tubing was also returned.Under magnification, the proximal end of the catheter exhibited jagged edges which is indicative of a tensile force applied to the catheter.The id of the catheter exhibited remnants of the catheter tubing confirming a extreme force had been applied to catheter.The most probable cause for the catheter tubing to detach from the catheter hub was most likely related to an event within the user environment.Possibly the tubing came in contact with isopropyl alcohol or acetone, as the ifu cautions against, that could weaken the catheter.Possibly during the dressing removal, a force was applied to the weakened catheter that resulted in the catheter pulling loose from the hub.A database analysis found no other similar complaints against this part or lot number regarding this issue.Since the reported issue was most likely related to an event within the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor issues of this nature in the future.

• Brand Name: ARTERIAL CATHETER MINI-KIT 20GA X 6"
• Type of Device: ARTERIAL CATHETER MINI 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: 16372324
• MDR Text Key: 309523408
• Report Number: 0001625425-2023-00965
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 00886333215546
• UDI-Public: 00886333215546
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 498101
• Device Catalogue Number: 498101
• Device Lot Number: 11448906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention