MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 18.0 INCH X 4.0 INCH; TOURNIQUET, PNEUMATIC

Catalog Number	5921-218-135NS
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : product was discarded.
Event or Problem Description
It was reported that the device inflated and then deflated during testing at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.H3 other text : product was discarded.
Event or Problem Description
It was reported that the device inflated and then deflated during testing at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 18.0 INCH X 4.0 INCH
• 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 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18371747
• Report Number: 3015967359-2023-02648
• Device Sequence Number: 15403124
• Product Code: KCY
• UDI-Device Identifier: 37613327606134
• UDI-Public: 37613327606134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: 5921-218-135NS
• Device Lot Number: 2023052204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2023
• 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