One sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and it was observed that the cuff deflated immediately.A visual inspection was performed and it was observed that the cuff presented a small tear.Manufacturing controls are in place to detect cuffs with damage and to reduce the potential for occurrence during the manufacturing process.Information has been added to the database and trends will continue to be monitored.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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