Investigations have been concluded for this reported issue by the manufacturer cheen houng enterprise.(b)(4) acts as distributer in the us.Only limited information was available.No sample was returned for investigation and no lot number was provided; therefore, the investigation is conducted based on the information given in the event description and experience and knowledge of the product.Possible root cause might be that the user tilted the device over 45 degrees during operation.The following safety information is given in the instructions for use of the device: the pump shall not be shaken while pumping or during use.The pump should not be tilted for the angles more than 45 degree while pumping or during use.If the pump handle becomes difficult to operate, a blockage may have occurred.Do not continue suctioning until the source of the blockage has been determined (remove the blockage from either the catheter, the adapter or the cap).Also disassembling the whole entire device is not a proper method of solving suction problem.Ifu clearly instructs in how to restore the suction ability without disassembling the whole device.The product risk evaluation includes the hazardous situation " no suction caused by a locked overfill protection due to user error ".The risk has been assessed with a severity of 3 (injury or impairment requiring professional medical intervention) and a probability of p=1 (occurs in <1/1.000.000).The risk is evaluated as acceptable and this incident does not change this conclusion.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to wrong file format.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.
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