MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

Catalog Number 384232

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546)

Patient Problems Extravasation (1842); Pericardial Effusion (3271)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

There were no samples available for review; however, a lot number was provided.A review of the device history record and inspection records was conducted and similar concerns were found.Without the sample to review, a definite root cause cannot be established.First picc catheters are 100% in-process inspected at various times during manufacture.Catheters are also leak, flow, and burst tested to ensure their integrity.Additionally, the instructions for use indicate several ways users can prevent catheter damage.

Event Description

Picc catheter presented extravasation (rupture) after 2 days of insertion.What in one patient led to a pericardial effusion.

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN
• Type of Device: FIRST 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: 7162282
• MDR Text Key: 96819591
• Report Number: 1625425-2017-00180
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2020
• Device Catalogue Number: 384232
• Device Lot Number: 11173915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2017
• 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