MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INTRACATH 19GA X 2" W/ 17GA X 2" NEEDLE

Model Number	384904
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.A follow-up report will be provided once the investigation is completed.
Event or Problem Description
The iv catheter lumen had a hole in it.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: INTRACATH 19GA X 2" W/ 17GA X 2" NEEDLE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10972594
• Report Number: 1625425-2020-00777
• Device Sequence Number: 3737908
• Product Code: FOZ
• UDI-Device Identifier: 00886333210145
• UDI-Public: 00886333210145
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K821372
• Number of Events Summarized: 1
• 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): 12/08/2020

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 Date: 09/30/2025
• Device Model Number: 384904
• Device Catalogue Number: 384904
• Device Lot Number: 11330491
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other