Qn#(b)(4).One lma proseal was returned from on grounds of "hole in mask prior to use on a patient".The record card received indicated that the device was used 20 times.The outer profile was yellowish due to multiple re-uses.The lot number and product were received as per the complaint description.The connector broke was not available because the cracked part was not received with the device.Other part of the connector was attached to the airway tube area.Autoclaving parameter adopted for reprocessing the devices were reported as per complaint description.It is possible that this could have been caused by the detergent or cleaning agent used, which might have weakened the connector.In addition, the mask has been used 20 times prior to this incident and therefore, this is not considered to be a manufacturing fault.The device history was reviewed, and no issues related to the connector was observed during the quality inspection.In conclusion, potential damage was caused by the detergent or cleaning agent used which might have weakened the connector.In addition, the mask has been used 20 times prior to this incident and therefore this is not considered to be a manufacturing fault.
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