(b)(4).One actual sample was received.The complaint sample was received with cannula which does not belong to teleflex product.The sample was closely examined by visual inspection.Based on the returned sample provided, the connector area of trach vent having stretch mark that was cause by the larger size of cannula.Therefore, the trach vent was having difficulty with removal from the cannula after connection.15mm ring gauge test was conducted on the connector of the canula.The connector side of the canula is out of the specification according to iso 5356-1:2015.It is larger than 15mm.In current manufacturing procedure, iqc department will conduct sampling gauge test before release the part item to production.In production, 100% visual inspection at assembly area is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.The customer complained that trach vent hme does not come off the cannula.Based on the gauge test conducted on returned sample, the connector of cannula is bigger and causing tight connection with trach vent.Since the canula does not belong to teleflex products, further investigation could not be performed.Therefore, this complaint could not be further verified.
|