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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

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ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM Back to Search Results
Model Number 384232
Device Problem Material Rupture (1546)
Patient Problem Laceration(s) (1946)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
The device used is indicated as available for evaluation. As of the date of this report, it has not been returned. A follow-up report will be provided once the device has been received and reviewed.
 
Event Description
Tip of the bevel damaged. Introducer opened at the time of the procedure, during venous puncture, ruptured in the vein of the newborn, causing a small lesion on the dorsum of the newborn in the right upper limb.
 
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Brand NameFIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
Type of DeviceFIRST PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key10593767
MDR Text Key209362448
Report Number1625425-2020-00535
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Pharmacist
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot Number11283860
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/28/2020 Patient Sequence Number: 1
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