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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
Model Number N/A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/22/2018
Event Type  Injury  
Manufacturer Narrative
The device has not been returned for evaluation so the complaint cannot be confirmed. If additional information is provided in the future, this issue will be reevaluated as needed.
 
Event Description
It was reported that the device, dislodged lower left extremity picc, which has embolized into the right pulmonary artery and overhangs into the right atrium. Piece was retrieved in interventional radiology. The only potential cause that was attributed to the break, could be the infant got her foot wrapped in the line.
 
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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 Contact
gail smith
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key8331072
MDR Text Key135873842
Report Number1625425-2019-00023
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 other
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/03/2021
Device Model NumberN/A
Device Catalogue Number384232
Device Lot Number11233993
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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 Received01/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
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