MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATH; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number 384540

Device Problem Fluid/Blood Leak (1250)

Patient Problem Venipuncture (2129)

Event Date 05/23/2018

Event Type  malfunction  

Event Description

A 28 gauge picc was placed in an infant without incident.An x-ray revealed that the picc was too deep and needed to be pulled back one cm.Once the picc was withdrawn it was noted that about 0.75 cm from the hub of the catheter there was a leak in the catheter.Catheter needed to be removed and a second picc placed.

• Brand Name: L-CATH
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 7609748
• MDR Text Key: 111391636
• Report Number: 7609748
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2018

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 Operator: Nurse
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 384540
• Device Lot Number: 11206411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/24/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1