MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921034235
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	09/30/2021
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: 3 events were reported for this quarter.Product return status: 3 device investigation types have not yet been determined.Additional information: 3 devices were labeled for single-use.3 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device reportedly had a decrease in pressure.1 event had no patient involvement; no patient impact.2 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, h1, h10.3 events were originally reported for this failure mode during the reporting quarter; however, 4 events were inadvertently excluded.7 reported events are included in this follow-up record.Product return status: 7 device investigation types have not yet been determined.
Event or Problem Description
This report summarizes 7 malfunction events in which the device reportedly had a decrease in pressure.5 events had no patient involvement; no patient impact.2 events had insufficient information received.
Event or Problem Description
This report summarizes 7 malfunction events in which the device reportedly had a decrease in pressure.- 5 events had patient involvement; no patient impact.- 2 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 7 previously reported events are included in this follow-up record.Product return status 3 devices were received.4 devices were not available for evaluation.

• Brand Name: DISP. 34X4, 1BLA, 2PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 00615 ; * 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12680369
• Report Number: 3015967359-2021-02352
• Device Sequence Number: 17175435
• Product Code: KCY
• UDI-Device Identifier: 37613154599470
• UDI-Public: 37613154599470
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 7
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2022

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: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 09/30/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 10/28/2021; 01/20/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown