MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC 26G (1.2F)

Catalog Number 384540

Device Problems Leak/Splash (1354); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record and inspection records was conducted and no similar concerns were found.One catheter was returned with a 10ml syringe attached.The catheter was tested using colored water in the attached syringe and leakage was confirmed.The most probable cause for the catheter leakage was due to excess tensile force that was applied during use.Since this issue most likely occurred in the user environment, no corrective action will be taken at this time.

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without incident.An x-ray revealed that the picc was too deep and needed to be pulled back one cm.Once the picc was withdrawn it was noted that about 0.75 cm from the hub of the catheter there was a leak in the catheter.Catheter needed to be removed and a second picc placed.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 PICC 26G (1.2F)
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 7720167
• MDR Text Key: 115361092
• Report Number: 1625425-2018-00081
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,07/25/2018

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: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 384540
• Device Lot Number: 11206411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention