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

Catalog Number	5922034235
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to the stryker sales representative that the tourniquet cuff leaked during a procedure.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported to the stryker sales representative that the tourniquet cuff leaked during a procedure.There were no reported adverse consequences; there were no significant procedure delays; there was no medical intervention required.The procedure was completed successfully.

• Brand Name: REUSE. 34X4, 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: 8235699
• Report Number: 0001811755-2019-00084
• Device Sequence Number: 276917
• Product Code: KCY
• UDI-Device Identifier: 07613154600113
• UDI-Public: 07613154600113
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 5922034235
• Device Lot Number: 50976107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1