Qn#(b)(4).The sample was received and forwarded to the supplier (hilbro) for evaluation.The supplier reports "after investigation we come to know that it happened because the stainless steel (aisi 304) balls used in these blades are soft.Although we normally use these balls in laryngoscope blades and it doesn't make any problem with brass handles, as brass is a soft material so it does not damage the balls and it work properly.In your case the handle is made of stainless steel material that is a hard material so after some use it damaged the soft stainless steel balls which make the balls stuck and caused the fitting problem." the supplier also reports "we have produced some samples with hard stainless steel (aisi 316) balls and checked several times on your stainless steel handles but the stainless steel balls did not damage and work properly.We have communicated the production workers to use hard stainless steel (aisi 316) balls for your product range so that this issue does not occur in future.This change has been implemented in the shipment dated (b)(6)2019 and will be implemented in all the future shipments." a scar has been opened against hilbro as a corrective/preventative action that will be taken to ensure material changes are managed per teleflex supplier quality procedures.
|