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

Model Number	384232
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Picc started reading high pressure on the iv pump and catheter did not aspirate or flush.When the staff were attempting to flush the catheter the catheter hub was collapsing on itself and not allowing the flush to be administered.The picc was in less than 4 hours.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications and a provided tracking number, there has been no sample returned for review.Additionally, there has been no visual evidence provided to support the alleged complaint.Without such evidence, conducting a thorough investigation is not possible, and therefore, this complaint could not be confirmed.Since this complaint could not be confirmed, establishing a definite root cause and an appropriate corrective action for the reported issue is not possible.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Common Device Name: 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: 21092563
• Report Number: 0001625425-2024-01178
• Device Sequence Number: 9105840
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: (01)00886333209750(17)270731(10)11584000
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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 Model Number: 384232
• Device Lot Number: 11584000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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