MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 34.0 INCH X 4.0 INCH; TOURNIQUET, PNEUMATIC

Catalog Number	5921-034-235NS
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : at this time device is not being returned.
Event or Problem Description
It was reported that the tourniquet cuff was set at 250 but would not reach that number during use in a procedure at the user facility.No medical intervention or adverse consequences were reported.The user facility was not able to provide any further information regarding the reported event.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
Event or Problem Description
It was reported that the tourniquet cuff was set at 250 but would not reach that number during use in a procedure at the user facility.No medical intervention or adverse consequences were reported.The user facility was not able to provide any further information regarding the reported event.

• Brand Name: COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 34.0 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: 16912299
• Report Number: 3015967359-2023-01098
• Device Sequence Number: 11325849
• Product Code: KCY
• UDI-Device Identifier: 37613327606189
• UDI-Public: 37613327606189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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: 5921-034-235NS
• Device Lot Number: 2022120503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1342-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown