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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN Back to Search Results
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.
 
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Brand NameFIRST PICC 26GA, SINGLE LUMEN
Type of DeviceFIRST 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 Key6777741
MDR Text Key82171875
Report Number1625425-2017-00102
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number384221
Device Lot Number11161286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
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 Treatment Data
Date Received: 08/09/2017 Patient Sequence Number: 1
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