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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICES INC. FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM Back to Search Results
Catalog Number 384232
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 03/08/2020
Event Type  malfunction  
Manufacturer Narrative
The sample device was indicated as available for evaluation. Argon has made three good faith efforts in requesting the return of the device, however, as of the date of this report the device has not yet been returned. Without such evidence, a root cause cannot be determined. If additional information is received in the future, the issue will be re-evaluated as needed.
 
Event Description
Picc inserted (b)(6) 2020. Picc removed (b)(6) 2020 due to cord formation on leg.
 
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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 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 Key9951059
MDR Text Key188207772
Report Number1625425-2020-00282
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/01/2005,03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384232
Device Lot Number11276377
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/11/2020 Patient Sequence Number: 1
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