Regulatory Focus™ > News Articles > FDA Questions How Company’s ‘Training Products’ Entered US Drug Supply Chain

FDA Questions How Company’s ‘Training Products’ Entered US Drug Supply Chain

Posted 09 March 2016 | By Zachary Brennan 

FDA Questions How Company’s ‘Training Products’ Entered US Drug Supply Chain

The US Food and Drug Administration (FDA) has sent untitled letters to two companies selling a medical product that is intended for training purposes only. The letters were sent more than eight months after recalling the product, which was linked to two deaths.

FDA said its investigation of adverse events associated with the use of Wallcur’s “Practi-0.9% Sodium Chloride” product identified several ways in which Florida-based PSS World Medical and Connecticut-based Moore Medical contributed to the introduction of the “simulation product” into the human drug supply chain and its use in patients.

“Our investigation indicated that your practices caused the introduction into interstate commerce of a product that you advertised, marketed and sold as 0.9% sodium chloride IV for use in treating human patients, but which was actually a simulation product,” FDA said to both companies in identical letters.

Last April, FDA sampled 11 of Wallcur’s simulated saline solution bags and identified large amounts of endotoxin and significant bacterial contamination in the samples. Wallcur says on its website that the products are for "training purposes only and are not intended for human or animal use."

FDA said at the time that it is aware of more than 40 individuals who received infusions of the simulated Practi-0.9% sodium chloride IV products; 26 of whom reported adverse events that ranged from flu-like symptoms to sepsis, a potentially life-threatening complication. Of those 26 individuals, two deaths and 11 hospitalizations were reported.

FDA is reiterating its previous recommendations that ask health care professionals and consumers to:

  • Visually inspect all current IV solution bags. Ensure none of the bags are labeled “Wallcur,” “Practi-0.9% sodium chloride,” or “For clinical training purposes only”;
  • Consider reviewing clinic procedures to ensure personnel can visually inspect all future shipments of IV products;
  • Seek medical attention if you were given a simulated Practi-0.9% sodium chloride product and you experience the symptoms described above;
  • Report any suspected adverse events associated with accidental or intentional exposure to simulated products to FDA’s MedWatch program online or at 1-800-332-1088.

FDA has been working closely with Wallcur to make changes to its labeling and distribution practices to prevent future occurrences.  FDA also has been working with the simulation medical products industry to highlight the risks associated with the incorrect use of these products.

Wallcur spokeswoman Susan Davis told Focus that the recall was last year and not this year, though the untitled letters are dated January 2016 and were just recently posted to FDA's website. She also referred us to a recall email address that did not work.

Untitled Letter for Moore Medical

Untitled Letter for PSS World Medical


Categories: Regulatory News

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