The mini dignity port was returned with approximately 18 cm of the lumen attached to the port stem.Visual inspection confirms the complaint as a hole can be seen on the bottom of the port.The material around the hole protrudes outward from the hole, indicating the source of the hole was from inside the port and not an exterior puncture.The septum was removed so that the hole could be viewed from inside the port.The port floor shows multiple scratches and gouges with the one through and through puncture hole.Information obtained from the facility indicates the needle is left insitu for extended periods of time but is to be changed out every 7 days.This could explain the number of scratches/gouges in the port floor.The puncture hole appears to be from a needle that was inserted too far, piercing the base of the port.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.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.A definitive root cause cannot be determined but is most likely not manufacture related.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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