MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC & L-CATH

Catalog Number 384232

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Pleural Effusion (2010)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

A review of the dhrs and inspection records were conducted and no similar concerns were found.Causes for pleural effusion include incorrect catheter tip placement and catheter migration (due to improper securement).This account does not employ an engineered securement device (i.E.Statlock) for the 384232, which can help keep the line in the right location.It was determined that the root cause of this complaint was not a catheter issue but was related to securement techniques by the healthcare facility.Current plans are to conduct care and maintenance training with this customer.

Event Description

On (b)(6) 2016 patient was diagnosed with a pleural effusion.Dressing/securement was with tegaderm and tape only.No engineered securement device used, no bio patch used.New l cath 26 ga picc was placed on (b)(6) 2016 and had to be removed the next day because of redness of a red streak.

• Brand Name: FIRST PICC & L-CATH
• Type of Device: FIRST PICC & L-CATH
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5764868
• MDR Text Key: 48640778
• Report Number: 1625425-2016-00030
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2016

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 Expiration Date: 03/31/2018
• Device Catalogue Number: 384232
• Device Lot Number: 11095703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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): Other