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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM

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ARGON MEDICAL DEVICES L-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM Back to Search Results
Model Number 28 GA (1.2F) X 25CM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Edema (1820)
Event Date 11/07/2020
Event Type  malfunction  
Manufacturer Narrative
The device is indicated as available for evaluation. As of the date of this report the device has not yet been returned. A follow-up report will be provided once it has been received and reviewed.
 
Event Description
Large amount body wall edema, pulled picc 11/4 placed 28ga single lumen picc in rt basillic vein.
 
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Brand NameL-CATH PICC SINGLE LUMEN 28GA (1.2F) X 25CM
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 Key11083270
MDR Text Key224602091
Report Number1625425-2020-00807
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Administrator/Supervisor
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number28 GA (1.2F) X 25CM
Device Catalogue Number384516
Device Lot Number11309937
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
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: 12/28/2020 Patient Sequence Number: 1
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