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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 Insufficient Information (4580)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device is indicated as unavailable for evaluation.Without the sample 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 or Problem Description
Item #384467/lot# 11267058 was inserted (date unavailable).On the 82nd day of dwell the hub experienced a little crack then split down the middle.
 
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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 Key10478276
Report Number1625425-2020-00498
Device Sequence Number19717452
Product Code FOZ
UDI-Device Identifier00886333209866
UDI-Public00886333209866
Combination Product (Y/N)N
Initial Reporter StatePA
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 Practitioner
Remedial Action Other
Type of Report Initial
Report Date (Section B) 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/05/2022
Device Model Number18GA (3.5F) 1.20 mm x 60 cm
Device Catalogue Number384467
Device Lot Number11271182
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/01/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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