MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH 26G (1.9F)0.60MM X 30CM L-CATH PICC

Catalog Number 384539

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed, and no similar concerns were noted. One catheter was returned for review. Visual inspection of the catheter found that the catheter tubing was separated from the hub. The exact root cause is unable to be determined based on the information available.

Event Description

A picc was leaking. Upon examination, the infant's picc dressing was saturated. The light purple sheath on the end of the picc had dislodged from the hub, and the picc line was moving through this sheath under the dressing. The resident was called to the bedside and ordered that the picc be removed. While removing the picc, the purple sheath completely disconnected from the hub.

• Brand Name: L-CATH 26G (1.9F)0.60MM X 30CM
• 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: 9183765
• MDR Text Key: 169237606
• Report Number: 1625425-2019-00264
• Device Sequence Number: 1
• Product Code: FOZ
• 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,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/11/2022
• Device Catalogue Number: 384539
• Device Lot Number: 11249993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 10/14/2019 Patient Sequence Number: 1