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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 Problems Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
The sample was returned for evaluation. A follow-up report will be submitted once the investigation has been completed.
 
Event Description
Iv pump began alarmed for occlusion around 0500. Rn investigated. Rn stopped infusion and attached saline flush. Upon flushing, rn noted leaking from the port/hub of the picc line (from the clear jelly part of the line). Rn notified physician. Physician ordered to place piv and dc picc line. Poc lytes and glucose obtained and indicated no concern in infants imminent nutritional status. Line likely failed only moments before occlusion alarm. No wetness was noted on infants linens. ¿ was a new piv or picc placed: ¿yes. Scalp piv. Infant very difficult iv stick and currently npo due to r/o nec. ¿.
 
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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 75751
Manufacturer Contact
gina liu
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key12425027
MDR Text Key271299010
Report Number0001625425-2021-01072
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
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,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Yes
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: 09/03/2021 Patient Sequence Number: 1
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