B. Braun Will Pay up to $7.8 Million to Avoid Criminal Prosecution After Sale of Contaminated Syringes
June 8, 2016 | Risk Management News
Medical device maker B. Braun will pay up to $7.8 million under an agreement with the U.S. Department of Justice to resolve criminal charges from the sale of contaminated saline syringes that led to at least five deaths, according to a May 18, 2016 article in the Allentown Morning Call. The German company, which has its U.S. corporate headquarters in Bethlehem, Pennslvania, faced criminal liability for selling contaminated syringes manufactured by another company, but will avoid prosecution by implementing procedures to improve oversight. B. Braun's director of marketing said in a statement that the business relationship with the third party, AM2PAT, "ended over eight years ago." The U.S. Food and Drug Administration's Office of Criminal Investigations began an investigation after a 2007 outbreak of bacterial infections sickened more than 100 patients nationwide. B. Braun began buying saline syringes from AM2PAT in 2006, the article said. The pre-filled syringes were intended to flush intravenous medical devices.