MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 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)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated that peripherally inserted central catheter (picc) line that has been placed on 2025 was found to be broken below the hub.Picc line removed in entirety.Patient required new picc line placement.
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.No samples were returned from the customer for review.Additionally, no photographic or visual evidence of any kind was provided, which would have allowed the allegation to be reviewed.Without necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action currently.As a result, no corrective action is required at this point.However, if samples are returned later, we would be happy to reopen this complaint for re-evaluation.Additional information provided in 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; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 76008 ; 9036759321
• MDR Report Key: 23407547
• Report Number: 0001625425-2025-01108
• Device Sequence Number: 8806991
• Product Code: LJS
• UDI-Device Identifier: 00886333209750
• UDI-Public: (01)00886333209750(17)280110(10)11605070
• 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: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 384232
• Device Lot Number: 11605070
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 MO
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White