Failure to Submit Medical Device Reports Leads to 483 for Metrix

Failure to submit medical device reports for its total parenteral nutrition bags landed Metrix an eight-item Form 483 following a May 2016 inspection of its Dubuque, Iowa, facility.

The firm manufactures on contract parenteral nutrition bags, transfusion filters and sets, IV bags and blood bags.

The company’s corrective action reports document two separate occasions that found that the compounding bags used for parenteral nutrition would not meet pumping accuracy with the high-speed compounder, the 483 says. The firm contacted a hospital customer and instructed it to scrap the bags, but it did not file a medical device report with the FDA, nor did it report that a correction or removal was needed to reduce a health risk. — Tamra Sami