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

Model Number 384221

Device Problem Blocked Connection (2888)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2023

Event Type  malfunction  

Event Description

We recently had an issue with one of our picc lines that stopped flushing in a patient.I have the picc in my office but of course we do not have the lot number as the packaging was thrown away¿.More info provided: 8/12/2023, at 0100 iv pump was reading occluded, flush attempted unsuccessfully, and the line is bubbling above the heart.Picc had to be removed and replaced.The harm done to the pt is that another invasive procedure was required.¿ date of picc insertion (b)(6) 2023.

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

We recently had an issue with one of our picc lines that stopped flushing in a patient.I have the picc in my office but of course we do not have the lot number as the packaging was thrown away¿.More info provided: (b)(6) 2023, at 0100 iv pump was reading occluded, flush attempted unsuccessfully, and the line is bubbling above the heart.Picc had to be removed and replaced.The harm done to the pt is that another invasive procedure was required.¿.Date of picc insertion (b)(6) 2023.

Manufacturer Narrative

A review of the dhr and inspection records could not be conducted since a lot number was not provided.One sample was returned for review.Visual inspection found no damage to the product.Functional testing with a water filled syringe confirmed an occlusion in the tubing within the neck of the silicone extension.The extension was cut by the analyst and a guidewire was inserted through the tubing within the silicone disc.Resistance to advance the wire was experienced initially but something broke loose allowing the wire to be fully inserted.Most likely there was flash present from the over molding process that resulted in the reported issue.The most probable cause for the reported issue was most likely related to the over molding process where the operator possibly misloaded the tubing onto the mandrel.There have been no other complaints regarding this issue with this part number and no lot number was provided.Most likely this was an isolated event.Since the reported issue was most likely an isolated event, no corrective action will be taken.However, argon will continue to monitor for issues of this nature in the future.

• Brand Name: FIRST PICC S/L BASIC KIT 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: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 17643170
• MDR Text Key: 322190614
• Report Number: 0001625425-2023-01187
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384221
• 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: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other