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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 Break (1069); Fluid Leak (1250); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device is indicated as available for evaluation. Argon has made three requests for the return of the device and as of the date of this report, it has not yet be returned. Without the sample or any visual evidence, the complaint cannot be confirmed. If additional information is received in the future, a follow-up report will be provided.
 
Event Description
Per the med watch report ¿while attempting a picc insertion, rn threaded catheter trough introducer into vessel and the line would draw and flush without difficulty. When attempted to advance catheter 2cm, catheter buckled under skin. Rn attempted to draw and flush line again and catheter then was leaking clear fluid out of the insertion site. When withdrawing the catheter out of the body, rn noted the catheter to be slightly fractured and then completely snapped in two parts when attempt was made to cut catheter segment for this report. All cm were accounted for 15 total, therefore no cm left inside body. ¿.
 
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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 Key10211894
MDR Text Key197916330
Report Number1625425-2020-00369
Device Sequence Number1
Product Code FOZ
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,Followup
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot Number11286356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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: 06/30/2020 Patient Sequence Number: 1
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