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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM
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ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM Back to Search Results
Model Number 18GA (3.5F) 1.20 MM X 60 CM
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/15/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is indicated as available for evaluation.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the sample is returned and reviewed.
 
Event or Problem Description
Picu rn mgr notified me that a 3.5 picc hub cracked on (b)(6) 2020.The picc was placed on (b)(6) 2020.
 
Additional Manufacturer Narrative
H3 other text: placeholder.
 
Event or Problem Description
Follow up.
 
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Brand Name
L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM
Common Device Name
L-CATH PICC
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX
MDR Report Key10121104
Report Number1625425-2020-00342
Device Sequence Number11619652
Product Code FOZ
UDI-Device Identifier00886333209866
UDI-Public00886333209866
Combination Product (Y/N)N
Initial Reporter StateWA
PMA/510(K) Number
K091670
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 06/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/29/2023
Device Model Number18GA (3.5F) 1.20 MM X 60 CM
Device Catalogue Number384467
Device Lot Number11293336
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date06/04/2020
Supplement Report FDA Received Date07/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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