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

Catalog Number	5921034135
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image of device was provided, actual device not available for evaluation.
Event or Problem Description
The sales representative reported that the cuff did not hold pressure 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 with a different device.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device was discarded by the customer, no evaluation is possible.Device discarded by customer.
Event or Problem Description
The sales representative reported that the cuff did not hold pressure 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 with a different device.

• Brand Name: DISP. 34X4, 1BLA, 1PRT, QUICK CONNECT
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8115402
• Report Number: 0001811755-2018-02601
• Device Sequence Number: 1553084
• Product Code: KCY
• UDI-Device Identifier: 37613154599456
• UDI-Public: 37613154599456
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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: 5921034135
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1