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

Model Number	384518
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
¿neonatal nurse practinoner inserted picc line successfully on a 25-week infant in nicu.When she went to withdraw the guidewire, she stated the wire severed the line.¿.
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.
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.Based on the product experience report, the customer indicated the sample was available for return.Several attempts were made to have the sample returned.Unfortunately, no samples have been returned for evaluation.Additionally, we did not receive any photographic or visual evidence that would have allowed us to further review your concern.Without the necessary evidence, we are unable to conduct a thorough investigation at this time.As a result, determining the root cause and corrective action is not feasible.If samples become available in the future, the complaint can be reopened for investigation.There are two similar complaints reported in the lot.Additional information provided in h.6.And h.11.

• Brand Name: L-CATH PICC S/L COMPLETE KIT 28GA (1.2F) X 25CM
• 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: 21633699
• Report Number: 0001625425-2025-00970
• Device Sequence Number: 21151399
• Product Code: LJS
• UDI-Device Identifier: 00886333209927
• UDI-Public: (01)00886333209927(17)251001(10)11597117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 10/01/2025
• Device Model Number: 384518
• Device Lot Number: 11597117
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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 Age: 5 MO
• Patient Sex: Unknown