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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
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ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 384539
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
Reporter indicated peripherally inserted central catheter (picc) line leaking at hub.Line needed to be removed.There was no patient injury.
 
Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
 
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Brand Name
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of Device
L-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
kelly mayer
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key18974931
MDR Text Key338992049
Report Number0001625425-2024-00971
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00886333209934
UDI-Public00886333209934
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number384539
Device Lot Number11478379
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/02/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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