MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. 1ST PICC S/L 26GA 1.9F X50CM; FIRST PICC

Catalog Number 384232

Device Problem Malposition of Device (2616)

Patient Problems Pleural Effusion (2010); Respiratory Distress (2045)

Event Date 03/18/2014

Event Type  Injury  

Event Description

It was reported that the patient exhibited signs of respiratory distress and a chest x-ray revealed that the tip was in pleural cavity.Medical/surgical intervention was required to prevent impairment damage or injury to the patient.(catheter migration, pleural effusion).The rn removed the catheter.It was not reported how much excess fluid was removed between the two pleural layer due to the pleural effusion.

Manufacturer Narrative

According to the information revealed, the patient had a picc line which was infusion tpn/lipids.The patient exhibited signs of respiratory distress and a chest x-ray revealed that the tip was in the pleural cavity.The picc line was discontinued and lipids were withdrawn from the patient's pleural cavity.A piv (peripheral iv) was placed for remainder of the patient's infusion therapy.Analysis of the returned complaint sample showed no abnormalities or defects.A pressurized fluid leak test was performed and no leaks were detected.The returned sample was found to be functional.Catheters are 100 percent inspected at various stages during the manufacturing process.A pressure test is performed on all catheters during manufacturing to ensure the catheters can withstand the pressure and forces when utilized within the instructions for use.A control pull test is also performed per the specifications.According to the ifu, picc catheters shall have the distal tip swelling in the lower one third of the superior vena cava to the junction of the superior vena and the right atrium.However, as indicated in the report the picc tip was in the pleural cavity which could cause respiratory distress.The ifu states that for proper use, clinicians must be familiar with and trained in the placement, maintenance, and use of picc catheters.The ifu has instructions for verification of proper placement of the catheter.The ifu also states that the external portion of the catheter must be adequately secured.The issue reported in this complaint was due to improper placement of the catheter or improper securement of the catheter which could result in catheter migration.

• Brand Name: 1ST PICC S/L 26GA 1.9F X50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; athens TX
• Manufacturer Contact: gail smith ; 1445 flat creek rd.; athens, TX 75751 ; 9722102562
• MDR Report Key: 3779708
• MDR Text Key: 4432787
• Report Number: 1625425-2014-00013
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 384232
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention