MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; TOURNIQUET, PNEUMATIC

Model Number	60-7070-103
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was returned to stryker sustainability solutions for an evaluation.Since the product packaging was not returned and a lot number was not provided, a review of the device history record was unable to be conducted.The device was functionally tested and was found to be non-hermetic, leaking at a rate of more than 1.0 l/min.The most likely root cause was determined to be excessive pulling/twisting on the tubing during use.The instructions for use (ifu) states: "avoid needles, towel clips, leg holders and other equipment that can puncture or otherwise damage the cuff." the reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that the device did not inflate and read low pressure.There was no patient injury, medical intervention, or extended procedure time reported.

• Brand Name: NA
• Common Device Name: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 6086001
• Report Number: 0001056128-2016-00143
• Device Sequence Number: 13623617
• Product Code: KCY
• UDI-Device Identifier: 00885825013851
• UDI-Public: (01)00885825013851
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/26/2016

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: Health Professional
• Device Model Number: 60-7070-103
• Device Catalogue Number: 60-7070-103RR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2016
• Initial Report FDA Received Date: 11/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1