MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 20GA (3F) 0.95MM X 65CM

Model Number	384156
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reporter indicated "attempted puncture in msd with single puncture, but catheter after migration when removing the guide wire it showed significant resistance, and when pulled the catheter curled, as if it had stuck.Because the extension had curled and we were able to remove the guide wire completely, when we performed the flush, we found a hole in the catheter near the cannon, making it impossible to keep the catheter in the patient.Device removed and emergency physician performed intracath passage.".
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the customer, there was no sample available for review.Additionally, there was no visual evidence provided that supported the alleged complaint.Without such evidence, the results are inconclusive, and this complaint could not be confirmed.Without the sample or evidence that supports the alleged complaint, establishing a root cause is not possible.Without the sample or evidence that supports the alleged complaint, establishing a root cause and corrective action is not possible.

• Brand Name: FIRST PICC S/L 20GA (3F) 0.95MM X 65CM
• Common Device Name: FIRST PICC S/L
• 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: 20033883
• Report Number: 0001625425-2024-01084
• Device Sequence Number: 16910287
• Product Code: FOZ
• UDI-Device Identifier: 00886333209675
• UDI-Public: (01)00886333209675(17)260728(10)11490524
• 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: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2026
• Device Model Number: 384156
• Device Lot Number: 11490524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown