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

Model Number	384516
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
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
¿leak¿ ¿at hub¿ ¿line had to be pulled¿ duration: ¿<1hr¿ notes: ¿picc line inserted and able to be advanced without issue.When i went to flush the line, it was leaking at the hub.Tried to tighten x 2 and then it continued to leak.Placed medline tubing and hub continued to have leakage with flush.Tried another med line tubing and it also continued to leak.Line was pulled.Hub did not appear to be cracked.¿.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for the provided lot was conducted.No deviations or non-conformances were found.One sample was returned for review.Visual inspection found no damage to the luer of the catheter.Functional testing by the analyst and again by sustaining engineering could not duplicate the reported issue of leakage at the hub.Even though the reported issue could not be duplicated with the returned sample, sustaining engineering is investigating other possibilities via project that might contribute to the reported issue experienced by the customer.The data from this project will aid in determining the root cause and an appropriate corrective action to be taken.Additional information provided in h.3., h.6.And h.11.

• Brand Name: L-CATH PICC S/L BASIC KIT 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: 21401206
• Report Number: 0001625425-2025-00943
• Device Sequence Number: 15507709
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)270213(10)11597657
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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
• Device Lot Number: 11597657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown