(b)(4).Report source - foreign.Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to the standard operating methods.The device was not received in the original teleflex lma packaging.The sample initially appeared to be missing the serial# from the airway tube.However, after further inspection the serial# was observed to be faded but readable.During the initial inspection a rip approximately 2mm long was observed on the orifice of the cuff very near the epiglottis elevator bar (eeb).The device was unable to hold inflation during the functional inspection due to the rip.When the device was immersed into water there were air bubbles observed escaping the device.Additionally, because of the rip on the cuff the eeb on the returned sample was easier to lift compared with the eeb of a retained sample.(see other remarks) other remarks: the reported complaint was confirmed through visual and functional inspection.The reported failure was suspected to be due to the device being torn inadvertently while being handled after some cycles of use.Customer is reminded that the lma reusable airway device should be handled with care while being reprocessed.Customer is also reminded the lma fastrach is reusable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from the date of purchase (whichever is earlier), subject to certain conditions.The product was manufactured in 2011 and has been out of warranty since 2012.
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