A visual inspection was performed on the returned device and the device was sent to the chemical lab (chem) for further analysis.The reported contamination/decontamination problem was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported contamination; however, factors that may contribute to a contamination include, but are not limited to, manufacturing, during shipment, sheath/stylet removal, storage or unpackaging of the device.In addition, a chem analysis was performed on the returned device which noted a strand of opaque, polymer-like material which was located coming from the inside lumen of the tip.It was concluded that the strand of opaque, polymer-like material from the lumen of the tip was not identified but resembled types of polyethylene.In this case, it is possible the strand of opaque, polymer-like material found in the lumen of the tip (polyethylene) may have occurred during sheath/stylet removal or during preparation of the device prior to use causing the reported contamination; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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