MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM

Model Number 384101

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

When opening the catheter for the procedure, the guide wire was removed, a 10ml syringe with 0.9% saline solution was connected and the flush was performed to fill the catheter.However, i observed saline leakage at the beginning of the catheter, just after the round transparent part, before the zero point.I also observed that the catheter is grayish in color in this area.

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.

Manufacturer Narrative

After three notifications and the closure date of this complaint, there has been no sample returned.Images were provided and were reviewed, however, the reported issue of leakage could not be confirmed.It was stated that leakage was observed upon flushing the catheter after the guidewire was removed.The flushing of the catheter should take place before removing the guidewire.If the guidewire is removed before flushing the catheter, the hydrophillic coating is not activated and may cause the catheter to rupture.Possibly the improper flushing of the catheter caused the reported issue of leakage.Based on the review of the provided images and without a sample to review, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, this complaint will be reopened for further review at that time.

Event Description

When opening the catheter for the procedure, the guide wire was removed, a 10ml syringe with 0.9% saline solution was connected and the flush was performed to fill the catheter.However, i observed saline leakage at the beginning of the catheter, just after the round transparent part, before the zero point.I also observed that the catheter is grayish in color in this area.

• Brand Name: FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM
• 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: 13480977
• MDR Text Key: 287927611
• Report Number: 0001625425-2022-00946
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209644
• UDI-Public: 00886333209644
• 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: Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384101
• Device Catalogue Number: 384101
• Device Lot Number: 11376562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other