Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: 13 not used (not opened) unit packs 101/860/090cz bluselect 9.0, suctionaid, cuffed, non-fen were received in plastic bag for investigation.10001429-006 infl.Line s/assy soft-seal 9mm is assembled in smiths medical tijuana therefore secondary investigation object was created with purpose to capture component investigation.Similar customer complaints have been recently received therefore internal non-conformity report ncr-000928 was created with purpose to evaluate this issue.Smiths medical tijuana site confirmed that no more physical complaint samples are needed for investigation therefore sample is kept in smiths medical czech republic.The cause of the reported problem could not be determined.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.Similar customer complaints have been recently received therefore internal non-conformity report ncr-000928 was created with purpose to evaluate this issue.
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