MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC 28 GA

Catalog Number 384540

Device Problems Partial Blockage (1065); Failure to Advance (2524)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing device history records and inspection records was conducted and no similar concerns were found.The catheter was returned with the access wire inserted.The splittable needle was also returned.The catheter and access wire were inserted through the needle with no issues.The needle inner diameter was dimensionally inspected, and it was within specification.Review of the returned product from the customer could not confirm the issue experienced.Since the alleged complaint could not be duplicated and the needle was found to be within specification, a definite root cause cannot be established with confidence.

Event Description

Needle introducer was inserted into the patient.When attempting to thread the catheter through the introducer, the catheter was unable to pass and so the picc could not be inserted into the patient.There is a blockage in the introducer.The introducer and picc had to be removed from the patient.This resulted in the patient needing multiple iv attempts.

• Brand Name: L-CATH PICC 28 GA
• 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: 7122672
• MDR Text Key: 95050106
• Report Number: 1625425-2017-00164
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2020
• Device Catalogue Number: 384540
• Device Lot Number: 11182875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2017
• 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