Three exactamix bags manufactured by baxter had particulate matter at (b)(6).Two bags last week and 1 bag this week were observed with particulate matter by a pharmacy technician upon examination prior to use.The first bag, on the inside filling port that connects to the compounding outlet, there was flaky black substance.This bag is no longer available and the lot number is unknown.On the second bag where the same filling port is, there is a black material in-between the tubing and the plastic that attaches to the compounder.This bag is available for evaluation, from lot 1028470, and is currently empty.With the third bag, the black material is on the outside of the lighter colored plastic piece that connects to the compounder.This bag is also from lot 1028470.This was noticed before there was any patient use.The second and third bags have been returned to baxter for their examination and review.All remaining bags with lot number 1028470 have been sequestered pending investigation by baxter.(b)(4).
|