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

Model Number	498106
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/02/2022
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
The connection point between the intra-arterial catheter and the stabilizing devise was broken and the catheter was retained in the artery.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.81 sealed samples were returned for review.Per the product experience report, there was no sample available for review and no defective product was returned with the sealed samples.Five random sealed samples were opened by the analyst and a pull test was conducted with no failures per op-qa-007 which allows for a destructive pull test of 1.75 lbs.Since the reported issue could not be duplicated per an examination of the returned product, no further evaluation was conducted.There have been no other complaints regarding this issue with this lot number.Since the reported issue could not be duplicated per an examination of the returned product, no further evaluation was conducted and no corrective action was taken.Argon will continue to monitor for issues of this nature in the future.
Event or Problem Description
The connection point between the intra-arterial catheter and the stabilizing devise was broken and the catheter was retained in the artery.

• Brand Name: ARTERIAL LINE KIT/1 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: 15960251
• Report Number: 0001625425-2022-01160
• Device Sequence Number: 5550153
• Product Code: FTN
• UDI-Device Identifier: 20886333215571
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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
• Device Model Number: 498106
• Device Catalogue Number: 498106
• Device Lot Number: 11444166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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