MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT; TOURNIQUET, PNEUMATIC

Catalog Number	5921030235
Medical Device Problem Codes	Material Puncture/Hole (1504); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the tourniquet cuff had holes and was leaking during a procedure.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully with a different tourniquet cuff.
Additional Manufacturer Narrative
Discarded.
Event or Problem Description
The user facility reported that the tourniquet cuff had holes and was leaking during a procedure.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully with a different tourniquet cuff.

• Brand Name: DISP. 30X4, 1BLA, 2PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9559295
• Report Number: 0001811755-2020-00028
• Device Sequence Number: 14047126
• Product Code: KCY
• UDI-Device Identifier: 37613154599432
• UDI-Public: 37613154599432
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 5921030235
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1