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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 384232
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned for evaluation and no images or videos have been provided, so the complaint cannot be confirmed. If additional information is provided in the future, this issue will be reevaluated as needed.
 
Event Description
Intravenous team ivt consulted for assessment of picc line (b)(6) day old patient with gastroschisis. Picc line for nutrition meds iv access staff nurse concerned with line "bubbling/with flushes". Unclear how long it had been happening or noted line assessed by ivt, recommendations to remove and not use due to concern for malfunction of line; new peripheral iv placed by iv team.
 
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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 Key9271709
MDR Text Key183163200
Report Number1625425-2019-00277
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 company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/23/2022
Device Catalogue Number384232
Device Lot Number11244512
Was Device Available for Evaluation? No
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 Received01/14/2005
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/23/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/04/2019 Patient Sequence Number: 1
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