MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN

Model Number 384221

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.

Event Description

Breakage of the introducer at the time of passage, preventing the catheter from passing through.

• Brand Name: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19138918
• MDR Text Key: 340793413
• Report Number: 0001625425-2024-00989
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384221
• Device Lot Number: 11430410
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1