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

Catalog Number 384221

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Hyperemia (1904); Phlebitis (2004)

Event Date 06/23/2017

Event Type  Injury  

Manufacturer Narrative

There were no samples or images returned for review; however, lot numbers were provided.A review of the device history records and inspection records was conducted and no similar concerns were found.Without the sample to review, a definite root cause and corrective action cannot be established.If the sample is returned at a future date, a follow up report will be submitted with the evaluation and conclusions.Per the clinical education manual that argon maintains, causes related to the complaint issue can be attributed to the handling of the device in the field.Possible causes of mechanical phlebitis includes the following: large catheter to vein size ratio, damage to tunica intima due to rapid or traumatic insertion, inexperienced catheter inserter, extensive movement of extremity, catheter movement within vein due to improper securement, cephalic and saphenous vein insertion, and/or glove powder or particulate matter on catheter.Possible causes of infectious phlebitis includes the following: introduction of bacteria into vein, improper hand hygiene, improper skin prep, and loss of integrity or wet dressing.

Event Description

Patient presented phlebitis, hyperemia, edema and palpable cord after the introduction of picc.

• 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: 6777741
• MDR Text Key: 82171875
• Report Number: 1625425-2017-00102
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/09/2017

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: 10/31/2018
• Device Catalogue Number: 384221
• Device Lot Number: 11161286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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