Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the device was yellow in color.It was also observed that there was a hole in the drain tube in the orifice area of the cuff.Under closer observation, there were signs of a puncture/cut on the drain tube.The cut was approximately 2mm long.A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint was confirmed.It is most likely that the cuff was punctured/cut inadvertently during handling.Lma devices should be handled with care.They are made of soft material and should be kept away from any objects with sharp and hard points.
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