MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number 384232

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be submitted upon investigation completion.

Event Description

Reporter indicated "catheter broke during usage¿no further details".There was no patient injury.

Manufacturer Narrative

A review of the dhr and inspection records was conducted for the provided lot, and no similar concerns were found.One sample was returned for review.The catheter tubing was returned in two pieces, confirming the reported issue of breakage.Visual inspection found the breakage ends of the tubing appeared to be straight with no jagged edges as thought the tubing had come in contact with a sharp object.The most probable cause for the breakage of the catheter tubing was most likely related to an event within the user environment.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• 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: 18872331
• MDR Text Key: 337304463
• Report Number: 0001625425-2024-00957
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 384232
• Device Lot Number: 11478691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2023
• 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