Dhr- lot 5271412 conformed to the specifications when released to stock.Failure analysis- the valve was visually inspected; it was noted that the silicone was cut/torn around the siphon guard, but the siphon guard was not returned with the valve.The needle guard was slightly raised.Some needle holes were noted in the needle chamber.The silicone housing around where the siphon guard should be, was visually inspected and what look like clamp marks were noted in the silicone housing.The valve passed the test for programming, occlusion and pressure.It was not possible to leak test or reflux test the valve due to the damaged silicone housing.The siphon guard could not be tested as it was not returned.The needle chamber was dismantled; the needle guard was slightly bent, and glue traces were noted on the needle guard and the silicone housing base.The root cause for the cuts/tears/marks in the silicone housing around the siphon guard is probably due to a sharp or pointed object coming into contact with the silicone, as noted in the ifu, silicone housing has a low cut/tear resistance.The root cause for the problem reported by the customer could be due to the slightly raised needle guard and the cuts/tears in the silicone housing this is probably due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway.
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