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

Model Number	384101
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001625425-2022-00946
• Device Sequence Number: 13897939
• Product Code: FOZ
• UDI-Device Identifier: 00886333209644
• UDI-Public: 00886333209644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown