The reported event was confirmed during the visual evaluation of the sample received.The sample was noted to have a dark loose foreign material, measuring 1/32".The sample was reviewed by the following requirement specified in the inspection procedure that states loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per tappi dirt estimation chart.Therefore the foreign material was found acceptable.The product was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "irrigation syringe after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Do not re-sterilize this is a single use device.Do not re-sterilize 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.".
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