Spontaneous.Patient reports that mini spike packages are not air-tight, and are thus not sterile.No obvious damage to packaging.Other airtight items in her supply were still okay.Multiple lot numbers al manufactured by braun.Listed one, but the others ended in 432, 428, and 486.Patient will use 18gauge needles to transfer fluid until new airtight minispike packages can be sent.Unknown if the patient missed a dose or experienced an adverse event as a result of the defective product.Unknown defective product expiration dates.Unknown if the pt has the defective product on hand for possible return to th manufacturer.No further information.Reference report #mw5117396, #mw5117398, #mw5117399.Reported to (b)(6) by pt/caregiver.
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