MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD. SPRAY CATHETER; ADAPTOR, CATHETER

Model Number	WP-18/2200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: kink in catheter prior to opening; unable to push product properly and causes leaks.

• Brand Name: SPRAY CATHETER
• Common Device Name: ADAPTOR, CATHETER
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.; 2855 broadway dr.; ann arbor MI 48104
• MDR Report Key: 24505660
• Report Number: 24505660
• Device Sequence Number: 13376062
• Product Code: GCE
• UDI-Device Identifier: 06932503562249
• UDI-Public: (01)06932503562249
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026
• Report Date (Section F): 02/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: WP-18/2200
• Device Catalogue Number: WP-18/2200
• Device Lot Number: M250104311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Date Report Sent to FDA: 02/26/2026