B. Braun fined up to $7.8m for sales of contaminated syringes

B. Braun Medical (B. Braun) has agreed to pay $4.8m in penalties and forfeiture and up to an additional $3m in restitution to resolve its criminal liability for selling contaminated syringes

The contaminated B. Braun pre-filled saline flush syringes were sold in 2007 and had a B. Braun label but were manufactured by another company, the Department of Justice (DoJ) announced. 

According to the agreed upon statement of facts that accompany the non-prosecution agreement, in March 2006, B. Braun started buying saline syringes from AM2PAT.

B. Braun was aware of manufacturing problems at AM2PAT, even before it began purchasing syringes from the company.  In the spring of 2007, AM2PAT notified B. Braun that it intended to move to a new manufacturing facility and change the company that would sterilise the B. Braun saline syringes through a new radiation sterilisation process. 

Before B. Braun’s quality department approved either of these changes, the company began selling the saline syringes made at AM2PAT’s new facility and sterilised by the new sterilisation company. 

B. Braun began to receive complaints about the syringes changing colour and information from AM2PAT that it was making changes to its radiation process but approved of these changes. 

Less than two months after B. Braun started selling syringes that AM2PAT made the company recalled all of them because the radiation sterilisation process caused dangerous white particles to develop in the saline inside the syringes. 

After the recall, AM2PAT told B. Braun that it gave the comapny incorrect information about its new radiation sterilisation process.  As explained in the statement of facts, even with this new information, B. Braun resumed buying the saline syringes from AM2PAT.

Less than a month after B. Braun resumed buying syringes from AM2PAT, the saline syringes were found contaminated with Serratia marcescens bacteria, which can cause blood infections.  

These contaminated syringes infected patients in California, Texas, New York and Nebraska.  The syringes were recalled.

The DoJ resolution for criminal liability includes a non-prosecution agreement that requires B. Braun to implement additional practices designed to increase its oversight of its product suppliers to prevent future sales of contaminated products. 

Principal deputy assistant attorney general, Benjamin Mizer, head of the Justice Department’s civil division, said: “The federal Food, Drug and Cosmetic Act (FDCA) prohibits companies from selling contaminated products, even when the company did not make the product itself.

“Companies must take reasonable steps to ensure that their suppliers are making quality products that help rather than harm patients. 

“Today’s settlement shows that the government will continue to hold companies accountable for failing to fulfill this critically important responsibility.”