(b)(4).Investigation summary: unfortunately, no sample was received for evaluation.A review of the internal production records for the lot involved could not be performed as lot number information was not provided.Per our process review, it was observed that the bag is a supplied component.This bag came taped to the bushing and then it is assembled to the elbow at carefusion¿s manufacturing plant.The detaching of the bag occurred between bag and bushing which is done at the supplier.Based on the investigation, at this time it¿s not possible to determine a root cause for the detachment of the bag.An investigation request was sent to carefusion¿s supplier to determine a root cause for the reported condition.At this time, a sampling of current inventory was visually inspected and no detaching problems were observed.All inspected bags were taped in a proper manner to the bushing.In order to prevent future occurrences, actions have been taken which include the following: 1.Current inventory of bag was placed in quarantine area and will not be used.2.New bag from supplier (nolato) was qualified and will be used for future production.
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