MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L (CENTRAL CATHETER BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN)

Model Number 384516

Device Problems Crack (1135); Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

Called at 8h30am to evaluate microclave (cracked ¿ visible smof/tpn) in chamber.Only available to do dressing/change extension at 16h.Extension changed.Unable to get blood return.Advised by dr.That probably picc is blocked, better remove it.Removed picc and tried to get blood return before but none.Insertion date: on (b)(6) 2023 (in situ 28 days) intervention: removed piv, changed iv diolytes solution.

• Brand Name: L-CATH PICC S/L (CENTRAL CATHETER BASIC KIT 28GA (1.2F) X 25CM 1 LUMEN)
• Type of Device: L-CATH 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: 18585087
• MDR Text Key: 333825437
• Report Number: 0001625425-2024-00929
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384516
• Device Lot Number: 11467300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• 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