The lot number was provided; therefore, a lot history review was performed.The sample was returned and the investigation confirmed for entrapment of the guidewire within the needle, contamination of the guidewire with foreign material (biological), deformation of the needle tip and improper procedure or method.The root cause for the reported event was confirmed and determined to be user-related.The device was labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the powerport products that are cleared in the us.The pro code for the powerport products is identified.
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This report summarizes one malfunction.A review of the reported information indicated that model 1806060j implantable port allegedly experienced unable to withdraw, entrapment of the guidewire within the needle, contamination of the guidewire with foreign material (biological), deformation of the needle tip and improper procedure or method.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
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