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

Model Number 498106

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/02/2022

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

The connection point between the intra-arterial catheter and the stabilizing devise was broken and the catheter was retained in the artery.

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 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"
• 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: 15960251
• MDR Text Key: 308028260
• Report Number: 0001625425-2022-01160
• Device Sequence Number: 1
• Product Code: FTN
• UDI-Device Identifier: 20886333215571
• UDI-Public: 00886333215577
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention