MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 30.0 INCH X 4.0 INCH; TOURNIQUET, PNEUMATIC

Catalog Number	5921-030-135NS
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 22 events were reported for this quarter.Product return status: 9 devices were not available for evaluation.13 device investigation types have not yet been determined.Additional information: 22 devices were labeled for single-use.22 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 22 malfunction events in which the device reportedly had a decrease in pressure.3 events had no patient involvement; no patient impact.11 events had patient involvement; no patient impact.8 events had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 22 previously reported events are included in this follow-up record.Product return status: 2 devices were received.10 devices were not available for evaluation.10 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 22 malfunction events in which the device reportedly had a decrease in pressure.3 events had no patient involvement; no patient impact.11 events had patient involvement; no patient impact.8 events had insufficient information received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h10 22 previously reported events are included in this follow-up record.Product return status 2 devices were received.12 devices were not available for evaluation.8 devices were evaluated based on historical data analysis.
Event or Problem Description
This report summarizes 22 malfunction events in which the device reportedly had a decrease in pressure.- 2 events had no patient involvement; no patient impact.- 12 events had patient involvement; no patient impact.- 8 events had insufficient information received.

• Brand Name: COLOR CUFF NON-STERILE DISPOSABLE TOURNIQUET CUFF 30.0 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: 16500402
• Report Number: 3015967359-2023-00518
• Device Sequence Number: 16969475
• Product Code: KCY
• UDI-Device Identifier: 37613327606158
• UDI-Public: 37613327606158
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 22
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2023

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: 5921-030-135NS
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023; 02/22/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/10/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 3228500
• Patient Sequence Number: 1
• Patient Sex: Unknown