MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT; Tourniquet, Pneumatic

Catalog Number	5921034235
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility the tourniquet would not stay inflated.The procedure was completed successfully without a clinically significant delay; no medical intervention or adverse consequences were reported.

• Brand Name: DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT
• Common Device Name: Tourniquet, Pneumatic
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Puerto Rico; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 24697252
• Report Number: 3015967359-2026-00197
• Device Sequence Number: 18757760
• Product Code: KCY
• UDI-Device Identifier: 07613154599479
• UDI-Public: (01)07613154599479(17)270516(10)2025052308
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2026

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 Catalogue Number: 5921034235
• Device Lot Number: 2025052308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown