MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARTERIAL LINE KIT/1 20GA X 6"

Model Number	498100
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Inserted (b)(6) 2022, left brachial in preparation for cabg surgery.Patient weaned from ventilator (b)(6) 2022, unceremoniously, but had not been transferred to bedside chair due to labile bp.Around 0730 on (b)(6) 2022, patient informed icu rn that she felt something wet on her arm.Seeing blood at the brachial site, rn removed the dressing and found the yellow hub of the brachial line, alone and slightly offset from the insertion site.Nurse searched for the catheter in the bed, could not locate it and notified the surgeon as the patient c/o a ¿pinching¿ sensation in her arm.Patient taken back to or and catheter retrieved from left arm vasculature.Specimen sent to pathology for identification and workup.No additional injury noted and patients left arm radial pulse was never impacted.
Event or Problem Description
Inserted (b)(6) 2022, left brachial in preparation for cabg surgery.Patient weaned from ventilator 12/04, unceremoniously, but had not been transferred to bedside chair due to labile bp.Around 0730 on (b)(6) 2022, patient informed icu rn that she felt something wet on her arm.Seeing blood at the brachial site, rn removed the dressing and found the yellow hub of the brachial line, alone and slightly offset from the insertion site.Nurse searched for the catheter in the bed, could not locate it and notified the surgeon as the patient c/o a ¿pinching¿ sensation in her arm.Patient taken back to operating room and catheter retrieved from left arm vasculature.Specimen sent to pathology for identification and workup.No additional injury noted and patients left arm radial pulse was never impacted.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One arterial catheter was returned for review.Visual inspection confirmed evidence of usage with the presence of dried bodily fluids on the catheter hub and inside the catheter tubing.The returned sample was returned in two pieces, the catheter hub that included the strain relief and the catheter tubing confirming the alleged complaint of breakage.The tubing end that was separated from the strain relief exhibited a stressed area in which the tubing was stretched out of shape.Upon closer examination under magnification, the breakage area of the tubing and inside the strain relief, jagged edges were observed.This kind of stress is indicative of a tensile force applied to the catheter.The most probable cause for the reported issue was most likely the result of an event within the user environment in which an excessive force was applied to the catheter resulting in the tubing pulling loose from the strain relief.There have been no other complaints regarding this issue with this part number or lot number.Since the reported issue was most likely the result of 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 for issues of this nature in the future.

• Brand Name: ARTERIAL LINE KIT/1 20GA X 6"
• 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: 16016836
• Report Number: 0001625425-2022-01163
• Device Sequence Number: 15137928
• Product Code: GDY
• UDI-Device Identifier: 00886333215539
• UDI-Public: 00886333215539
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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 Model Number: 498100
• Device Catalogue Number: 498100
• Device Lot Number: 11434833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown