Pre-Filled Syringes Shipped by Manufacturer Knowing They Weren’t Sterile

According to federal prosecutors, tainted pre-filled syringes were shipped from a North Carolina plant by AM2PAT, Inc., with knowledge that they were not sterile and could pose a substantial health risk.

Hundreds of people were injured and at least five were killed as a result of an outbreak of infections caused by Sierra heparin syringes and saline syringes that were recalled by the company in January 2008.

Two employees pled guilty on Monday in the U.S. District Court for the Eastern District of North Carolina, in Raleigh, for falsifying records and for allowing unsterile syringes to be shipped to consumers. Authorities are continuing to search for the owner of the company, Aniruddha Patel, who they believe may have fled the country.

In 2006 and 2007, AM2PAT, Inc. shipped nearly $7 million worth of pre-filled heparin lock-flush syringes and saline flush syringes that did not go through proper sterility testing and were not made in accordance with good manufacturing standards. They were sold under the brand names “Sierra Pre-Filled” and “B. Braun.”

Many of these pre-filled syringes, which were used both at hospitals and in homes, were found to be contaminated with Serratia marcescens bacteria. About 200 to 300 people were infected with the bacteria, which could cause severe illness, permanent brain damage and spinal meningitis.

The plant manager, Aniruddha Patel, and the quality control director, Ravindra Kumar Sharma, received relatively light sentences of 4 1/2 years each in exchange for providing information about the owner of the company, who has been indicted on 10 charges of fraud and selling adulterated medical devices.

According to prosecutors, the company intentionally bypassed internal checks ensuring the safety of the syringes, backdated reports to make it appear that the syringes had passed inspections and fabricated test results.

Sterility rules were also disregarded to increase the speed of production, and syringes were not filled in a “clean room,” which is supposed to be designed to keep germs from contaminating the product.

On December 20, 2007, about 17,000 Sierra Pre-Filled Heparin syringes were recalled (5 mL in 12 mL syringes) after at least 40 serious infections were reported among users who were infected with Serratia marcascens bacteria.

On January 18, 2008, the syringe recall was expanded to include all lots of both heparin syringes and saline syringes manufactured by the company, which were sold in 3 mL, 5 mL and 10 mL sizes.

A number of heparin syringe lawsuits have been filed against AM2PAT, Inc. on behalf of individuals who were infected with the Serratia marcencens bacteria.