MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC SL KIT; CATH,INTRAVASC,THERAP,SHORT-TERM LESS 30DAYS

Catalog Number 384232

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Phlebitis (2004)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

The device was still in use; therefore, no evaluation of the device could be performed.No further information has been ascertained in relation to the patient's status.If further information is obtained in the future, a follow-up report will be submitted.

Event Description

First picc s/l demonstrated early signs of phlebitis.The md instructed primary care rn to apply heat for one hour and discovered mild improvement from the vein.The catheter is currently in place until further evaluation.The catheter was inserted on (b)(6) 2018 and trimmed to 12 cm.

• Brand Name: FIRST PICC SL KIT
• Type of Device: CATH,INTRAVASC,THERAP,SHORT-TERM LESS 30DAYS
• 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 ; 4697311415
• MDR Report Key: 7547275
• MDR Text Key: 109357426
• Report Number: 1625425-2018-00054
• 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: 05/27/2018

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: 02/01/2023
• Device Catalogue Number: 384232
• Device Lot Number: 11206023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention