MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA(1.9F) X 50CM

Model Number	384222
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The investigation is ongoing.A follow-up report will be provided once it has been completed.
Event or Problem Description
The picc broke in half, the catheter itself.
Additional Manufacturer Narrative
H3 other text : placeholder.
Event or Problem Description
Follow up.

• Brand Name: FIRST PICC S/L 26GA(1.9F) X 50CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10222130
• Report Number: 1625425-2020-00379
• Device Sequence Number: 19035556
• Product Code: LJS
• UDI-Device Identifier: 00886333223220
• UDI-Public: 00886333223220
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2020

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 Date: 02/28/2022
• Device Model Number: 384222
• Device Catalogue Number: 384222
• Device Lot Number: 11290530
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1