The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used ellik evacuator.Visual inspection of the sample noted the yellow tube adapter was disconnected from the evacuator.This is out of specification per inspection procedure which states, "the union between the recipient and the tube adapter, it must be free and clear of bubbles and openings that could weaken the sealed; manually pull the recipient and tube adapter to assure that the united parts do not separate easily.A potential root cause could be components out of specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." the actual/suspected device was inspected.
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