The 8f dignity port was received for evaluation.Additional information was requested from the reporting facility.Dr.(b)(6) indicated that he cannot answer the questions and would not compete the product incident report.They did not place the port at their hospital.The patient came from another hospital.The port was accessed in the er and then the patient was sent to ir for a port check because they could not pull out the huber needle.Visual examination confirmed the report.There is a hole through the base of the port that leaks when the port is flushed.The septum was removed in order to obtain dimensions.The port floor shows some minor scratches with the one through and through puncture hole.Relative dimensions were taken, including the thickness of the port floor thickness which measured.040 putting it within specification of between.035 and.045.All dimensions taken show the device is within specification.The contract manufacturer conducted a review of the manufacturing records for the lot reported.The review showed the device was manufactured according to specification with no anomalies or non-conformances.Product validation determined the average force required to pierce the port base floor with 19 and 22 gauge huber style needles.For the 19 gauge needle the average force was 15.91 lbs with a minimum force of 14 lbs.For the 22 gauge needles the needles bent at an average force of 4.62 lbs and did not penetrate the base floor.We are unable to determine the cause of this event.Excessive force may have been used when accessing the port.The health professional inserting the needle into the port may have misjudged the depth of the port and the amount of force necessary to access the port, thus causing the needle to go through the port base.
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