MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. ARTERIAL LINE KIT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 498412B

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Information (3190)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

The doctor began to use an 18ga x 6" arterial line kit when the doctor observed that the wire was kinked/bent at about a 45 degree angle.The doctor requested another kit due to the bent wire, but it was discovered that the additional kits in stock had bent wires, also.The doctor was able to bend the wire enough to use/advance the wire so that it did not affect the patient negatively.Stock was examined and all kits in stock (same lot number of 11039131) had similarly bent wires.The kits were pulled and the manufacturer has been notified.

• Brand Name: ARTERIAL LINE KIT
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 3567454
• MDR Text Key: 4055823
• Report Number: 3567454
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/09/2014
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 498412B
• Device Lot Number: 11039131
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1