MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC S/L 28GA (1.2F) X25CM BASIC W/SN

Catalog Number 384516

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pleural Effusion (2010)

Event Date 03/26/2014

Event Type  Injury  

Event Description

Patient required intubation and chest tube.Line was removed.Customer believes medical intervention was required due to misplacement of catheter, and not an issue with catheter itself.Note: customer does not believe there is an issue with this catheter, but kept it for evaluation because of a complication that happened with patient (pleural effusion).

Manufacturer Narrative

As reported in the complaint, the customer believed medical intervention was required due to misplacement of catheter, and not due to an issue with catheter itself.It is unknown if the issue was observed immediately after the catheter was inserted or after the catheter was implanted for a period of time.The complaint product was not returned for evaluation.A review of the device history records revealed no discrepancies which would cause the issue.Catheters are 100 percent inspected at various stages of the manufacturing process.A pressure test is performed on all catheters during manufacturing to ensure the catheters can withstand the pressures 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 dwelling in the lower one third of the superior vena cava to the junction of the superior vena and the right atrium.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 on this complaint was probably due to improper placement of the catheter as asserted by the customer.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X25CM BASIC W/SN
• Type of Device: 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: 3788313
• MDR Text Key: 4442128
• Report Number: 1625425-2014-00014
• 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: 04/28/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: 384516
• Device Lot Number: 11046122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• 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