MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC D/L 16GA (5F) 1.75MM X 65CM

Model Number	384159
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as unavailable for evaluation.Without the device or any images 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
Picc catheter presented leakage at the 9cm length.

• Brand Name: FIRST PICC D/L 16GA (5F) 1.75MM X 65CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10852829
• Report Number: 1625425-2020-00709
• Device Sequence Number: 3228674
• Product Code: FOZ
• UDI-Device Identifier: 00886333209705
• UDI-Public: 00886333209705
• Combination Product (Y/N): N
• PMA/510(K) Number: K972263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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: 04/08/2022
• Device Model Number: 384159
• Device Catalogue Number: 384159
• Device Lot Number: 11253266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2020
• 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