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

Catalog Number	5921034135
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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: 28 events were reported for this quarter.Product return status: 28 device investigation types have not yet been determined.Additional information: 28 devices were labeled for single-use.28 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 28 malfunction events in which the device reportedly had a decrease in pressure.13 events had no patient involvement; no patient impact.15 events had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 28 previously reported events are included in this follow-up record.Product return status 12 devices were received.16 devices were not available for evaluation.
Event or Problem Description
This report summarizes 28 malfunction events in which the device reportedly had a decrease in pressure.14 events had no patient involvement; no patient impact.14 events had patient involvement; no patient impact.

• Brand Name: DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• MDR Report Key: 12204166
• Report Number: 3015967359-2021-01631
• Device Sequence Number: 19890094
• Product Code: KCY
• UDI-Device Identifier: 37613154599456
• UDI-Public: 37613154599456
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 28
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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
• Operator of Device: No Information
• Device Catalogue Number: 5921034135
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1