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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC D/L 16GA (5F) 1.75MM X 65CM

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ARGON MEDICAL DEVICES FIRST PICC D/L 16GA (5F) 1.75MM X 65CM Back to Search Results
Model Number 384159
Device Problem Material Perforation (2205)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2020
Event Type  malfunction  
Manufacturer Narrative
The sample is indicated as unavailable for evaluation. Without any evidence to review, the complaint cannot be confirmed. If additional information is provided in the future, a follow-up report will be submitted.
 
Event Description
"the picc 5fr catheter was passed, but at the end of insertion it was observed that the extension near the oval disc was perforated ".
 
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Brand NameFIRST PICC D/L 16GA (5F) 1.75MM X 65CM
Type of DeviceFIRST PICC
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 Key11310620
MDR Text Key232544193
Report Number1625425-2021-00842
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209705
UDI-Public00886333209705
Combination Product (y/n)N
PMA/PMN Number
K972263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/08/2022
Device Model Number384159
Device Catalogue Number384159
Device Lot Number11253266
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
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: 02/10/2021 Patient Sequence Number: 1
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