The CDC confirmed 14 cases of bloodstream infections in children across four U.S. states that may be connected to heparin and saline syringes distributed by medical technology company Becton Dickinson and Co., according to Reuters.
The 14 bloodstream infection cases were caused by the same strain of the Serratia marcescens bacterium, Kiran Mayi Perkins, MD, the CDC's lead investigator on the outbreak, told Reuters.
The infections occurred in seriously ill children who were receiving intravenous medications through a catheter or central line, which delivers medications such as chemotherapy.
The confirmed infections were found in Tennessee, Colorado, Minnesota and Ohio. There were no deaths as a result of the outbreak, and most of the affected children were recovering well, Dr. Perkins said. The number of cases appears to be winding down, Dr. Perkins added.
Health officials started investigating the Becton Dickinson products after finding the syringes had been used to treat several of the infected children. To keep them clear, central lines are often flushed with saline or heparin, a blood thinner. As of yet, none of the Becton Dickinson products have tested positive for the bacterium.
In April, Becton Dickinson recalled 949 lots of its BD PosiFlush Pre-Filled Heparin Lock Flush Syringes and Pre-Filled Normal Saline flush syringes sold between February and December 2017 out of "an abundance of caution." The company said it was cooperating with the FDA and CDC during the investigation.
"The company immediately initiated an internal investigation after being notified of a potential connection between catheter-related blood stream infections and the Serratia marcescens bacterium," BD said in an emailed statement to Reuters.
The company had checked records from its sterility testing, environmental testing and clean room validation, BD spokesperson Troy Kirkpatrick told Reuters via email. "To date, no BD flush product has ever tested positive for this bacterium."
If there is contamination, it is "probably a very low amount," making it difficult to test for, Dr. Perkins said. "Although the product tests have been negative to date, again, in an abundance of caution, we continue to take the steps we have," she said. "That's probably why BD has done the recall as well."