MAUDE Adverse Event Report: STRYKER CORPORATION COLOR CUFF; TOURNIQUET, PNEUMATIC

Model Number	5921030235
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When we went to inflate the tourniquet, the tourniquet was leaking.

• Brand Name: COLOR CUFF
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 22564385
• Report Number: 22564385
• Device Sequence Number: 13070790
• Product Code: KCY
• UDI-Device Identifier: 07613154599431
• UDI-Public: (01)07613154599431(17)260423(10)2024041506
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/17/2025
• Report Date (Section F): 07/17/2025

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 Model Number: 5921030235
• Device Catalogue Number: 5921-030-235
• Device Lot Number: 2024041506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• 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 Age: 16 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Date Report Sent to FDA: 07/17/2025