(b)(4).Visual inspection was performed to 1 piece from product code dp-48k (pu dp-48k disp punch 4.8mm) received as part of this complaint, piece is received without damage; this sample was not received in its original packaging.Dimensional testing according to was performed to the metal components once disassembled obtaining acceptable dimensional results.As per quality form qa-pun-003/f1, the unit was activated by triggering the device in order to detect any obstructions and to show a smooth return of the metal core, sample available did not show any problem during this testing.The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No corrective actions can be established since the visual, dimensional and functional testing demonstrated that product was manufactured according to the specifications.The customer complaint is not confirmed since the sample received has been found within the dimensional and functional requirements.Teleflex will continue to monitor and trend related events.
|