MAUDE Adverse Event Report: TIDI PRODUCTS LLC GL CVC SECUREMENT DEVICE ST; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	3601CVC
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: photographic evidence provided by the reporting site shows small, light-colored fiber-like particles located on or adjacent to the device surface within the pouch.No patient injury or adverse clinical impact has been reported in association with this event.An investigation was initiated, including communication with manufacturing personnel and review of available production and inspection records for the affected lot(s).Based on the information available to date, the observed condition is consistent with incidental fiber contamination potentially introduced during manufacturing or packaging operations.At the time of this report, the investigation remains open pending completion of additional manufacturing review activities.No definitive root cause has been confirmed.Appropriate quality system processes have been engaged, and any necessary corrective or preventive actions will be implemented based on final investigation outcomes.Manufacturer reference file: (b)(4).
Event or Problem Description
During the acceptance inspection, non-conforming products were detected.Foreign object debris found in 12 devices.

• Brand Name: GL CVC SECUREMENT DEVICE ST
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 25191961
• Report Number: 2182318-2026-00046
• Device Sequence Number: 10385277
• Product Code: KMK
• UDI-Device Identifier: 00618125135011
• UDI-Public: 00618125135011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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
• Device Model Number: 3601CVC
• Device Catalogue Number: 3601CVC
• Device Lot Number: 70616837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown