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

Model Number	384232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample has been returned for investigation and is currently in process.A follow up report will be submitted upon the closure of the investigation.
Event or Problem Description
The infant was having its vitals taken and being repositioned.The nurse saw it snap "[at the hub]", grabbed it and had the medical team attend the bedside to remove.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non¿conformances.One sample was returned by the customer for evaluation that supported the reported allegation.Upon inspection, it was found that the picc line had snapped at the hub.The most likely cause appears to be the application of excessive force by the user.As the observed failure is consistent with user handling, no corrective action is needed.Additional information provided in h.3., h.6.And h.11.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Common Device Name: CATHETER INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 25337648
• Report Number: 0001625425-2026-00968
• Device Sequence Number: 21353493
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: (01)00886333209750(17)251216(11)11455198
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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: 12/16/2025
• Device Model Number: 384232
• Device Lot Number: 11455198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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