It was reported that particulates were observed in an unspecified number of 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags.This was identified in multiple bags after being filled, prior to use on patients.It was further reported that some of the particulates "were obvious scrapings from the ports".The customer reported they used only 18 gauge needles to reconstitute, withdraw, and push into the bags.Some of the bags were filled with methylprednisolone 2.5; others with antibiotics: cefepime, cetriaxone, meropenem, cefazolin, ampicillin, and unasyn (the exact quantities of each were unspecified).It was stated that this was identified ¿after the 7pm fill¿ and when the bags were stored in the refrigerator.There was no patient involvement.No additional information is available.
|
H4: device manufactured between july 23, 2020 to july 24, 2020.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|