MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN); CATHETER, INTRAVASCULAR THERAPEUTIC

Model Number	384516
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The picc leaked at the juncture of the hub and the microbore extension set.This happened three times and the picc had to be exchanged each time the picc leaked.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.No samples were returned from the customer for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, determining root cause or corrective action is not possible.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.Additional information provided in h.6.And h.11.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
• 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 75751 ; 9036759321
• MDR Report Key: 22197948
• Report Number: 0001625425-2025-01031
• Device Sequence Number: 8593977
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 384516
• 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: 05/16/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown