(b)(4).The customer returned one 18 ga introducer needle with lidstock for evaluation.Signs of use in the form of biological material were present on the needle.Visual analysis revealed one large crack in the needle hub.Microscopic examination confirmed the defect.The returned needle was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu states, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate." the returned introducer needle was connected to a lab inventory ars syringe to functionally test.When the syringe and needle were used to aspirate, air bubbles entered the syringe body.When the syringe and needle were used to expel water , water leaked from the crack in the hub.The hub of the needle was tested with the male luer gage and was within the specified range.This indicates that the luer conforms to iso 594-1:1986.R and d was contacted to identify a potential root cause.According to r and d, material brittleness can be caused by various factors such as raw material variability, molding conditions, storage conditions, transport conditions, and exposure to chemicals.For this reason, a specific root cause could not be determined at this time.A device history record review was performed, and no relevant findings were identified.The reported complaint of a cracked needle hub was confirmed by a complaint investigation on the returned sample.The returned introducer needle contained one crack in the hub.A device history record review was performed, and no relevant findings were found.Based on the customer description, sample returned, and discussion with r and d engineers, a root cause could not be established at this time.Teleflex will continue to monitor and trend on complaints of this nature.
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