Braun Medical Pays $7.8 Million for Contaminated Saline Syringes
Pennsylvania- and Germany-based company B. Braun Medical has agreed to pay nearly $8 million after being accused of selling saline syringes fraught with contamination. Braun purchased the syringes from Am2Pat, a manufacturing company, even though it had acquired information prior to the purchase indicating that the syringes suffered from manufacturing issues at the plant in North Carolina where they were produced. Two months after Braun purchased the syringes, it initiated a recall based on information indicating that the radiation sterilization process used caused the saline to develop particulates.
Following the recall, Am2Pat stated that it had not provided correct information to Braun before the sale of the syringes. According to this information, the manufacturing company had installed new equipment at its plant without first ensuring that the equipment was in good working order following the move. Despite this provision of information, Braun started purchasing saline syringes from Am2Pat again and did not conduct its own independent inspection of the manufacturing facility prior to doing so.
Roughly one month later, the syringes were found to contain a dangerous bacteria called Serratia marcescens. Patients in New York, Texas, California, and Nebraska reported experiencing illness and contamination as a result of using the syringes. A second recall of this batch of syringes was also initiated.
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