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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 Fluid/Blood Leak (1250); Flushing Problem (1252); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2020
Event Type  malfunction  
Manufacturer Narrative
The device is indicated as unavailable for evaluation. Without the device or any visual evidence to review, the complaint cannot be confirmed. If additional information is received in the future, a follow-up report will be provided.
 
Event Description
The patient maintained picc monolumen 1. 9 fr in right lower limb (inserted on (b)(6) 2020 and was transferred from the neonatal center to ctin2 on (b)(6) presenting a catheter with blood in extension and resistant to salinization. On october /10 wet dressing was observed and when removing the identified microhole dressing. Pulled out picc and not forwarded tip to culture. There was no need to insert new venous access, it maintained only medications via enteral. Catheter data: argon brand (1. 9 fr), silicone material, lot 11304081.
 
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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
Manufacturer Contact
gina liu
1445 flat creek rd, athens, tx 75751
MDR Report Key11041663
MDR Text Key223184145
Report Number1625425-2020-00803
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209750
UDI-Public00886333209750
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot Number11304081
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/25/2020
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: 12/18/2020 Patient Sequence Number: 1
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