B. Braun Pays $8 Million to Settle Contaminated Syringes Case
B. Braun Medical has agreed to pay the U.S. government $7.8 million to resolve its criminal liability for selling contaminated pre-filled saline flush syringes in 2007. The syringes had a B. Braun label but were manufactured by another company, according to a Justice Department (DoJ) release. The settlement also calls for a non-prosecution agreement that requires B. Braun to implement additional practices designed to increase its supplier oversight to prevent future contaminated product sales.
“Companies must take reasonable steps to ensure that their suppliers are making quality products that help rather than harm patients,” the release says. “This agreement helps to provide justice for the victims and to deter such future conduct by distributors of medical devices.”
DoJ contends B. Braun began in 2006 buying saline syringes from AM2PAT, Inc.,which manufactured them at a small facility in North Carolina. “As noted in the statement of facts, B. Braun was aware of manufacturing problems at AM2PAT, even before it began purchasing syringes from AM2PAT,” it says. In separate audits, both FDA and B. Braun he found that AM2PAT was having problems complying with GMPs.
In 2007, AM2PAT notified B. Braun that it was moving to a new manufacturing facility and it was changing the company that would sterilize the saline syringes through a new radiation sterilization process. “Before B. Braun’s quality department approved either of these changes, B. Braun began selling B. Braun saline syringes made at AM2PAT’s new facility and sterilized by the new sterilization company,” DoJ says. “B. Braun later approved both of these changes even though B. Braun had already received complaints about the syringes changing colors and information from AM2PAT that it was making changes to its radiation process to avoid ‘overcooking’ the syringes. B. Braun approved AM2PAT’s facility move without ever seeing AM2PAT’s operations at its new facility or confirming AM2PAT’s representations that it had properly validated its clean room and equipment after the move.”
Subsequently, B. Braun recalled all syringes because the radiation sterilization process caused dangerous white particles to develop in the saline. After the recall, according to the government, AM2PAT told B. Braun that it gave B. Braun incorrect information about its new radiation sterilization process. It also sent B. Braun information showing that AM2PAT moved manufacturing equipment to its new facility without validating that the equipment worked as expected after the move. “As explained in the statement of facts, even with this new information, B. Braun resumed buying B. Braun saline syringes from AM2PAT without going to AM2PAT’s new facility,” it says.
Less than a month after B. Braun resumed buying syringes from AM2PAT, the syringes were discovered to be contaminated with Serratia marcescens bacteria, which can cause blood infections. “These contaminated syringes infected patients in California, Texas, New York and Nebraska,” DoJ says.
Under the terms of the agreement, the government says B. Braun will increase oversight of its product suppliers by conducting on-site audits and testing products for sterility, identity and purity, as appropriate, on a periodic basis. B. Braun also agreed to be monitored by an independent compliance auditor during the term of the agreement.