(b)(4).Date of event unknown.Initially, this was reported as a duplicate case, but an additional sample was returned and evaluated at a later date.The batch review did not find any nonconformances related to the reported condition during the manufacture of this device.The visual inspection identified the reported issue and confirmed that the fill port tubing had been damaged, resulting in the fill port connector/cap assembly being removed.The damage to the fill port tubing was determined to have been caused by the tubing being misaligned in the manufacturing equipment during fill port installation.Manufacturing controls are in place to reduce the likelihood of recurrence of this defect including startup and 100% final visual inspection, as well as in process inspection.Should additional relevant information become available, a follow-up report will be submitted.
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