News Tagged ‘AM2PAT

Watchdog group pressures FDA about contaminated syringes

Watchdog group Project on Government Oversight (POGO) is asking the () inspector general to investigate why the agency failed to stop contaminated syringes from reaching the public that caused four deaths and 162 serious injuries to individuals who were treated with the tainted products.

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FDA should have acted faster to prevent contamination

Leslie Fullerton provided the best care he could for his 29-month-old daughter Natalie with the medical equipment and medications provided him, but he still blames himself for her death. The little girl had already undergone a double-lung transplant and was recovering nicely when her father, following instructions of his daughter’s health care provider, used a pre-filled syringe to clean the tube implanted in Natalie’s chest to give her intravenous medication. Days later, Natalie became breathless and feverish as a bacteria infected her blood. Months later, Natalie died.

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Father blames FDA for not taking precautions to protect son

Dusty Martin blamed himself after almost losing his 8-year-old son Michael to a bacterial infection. The boy is a hemophiliac who needs regular injections of medicine to reduce the risk of bleeding to death from a slight cut. Martin uses pre-filled syringes of saline and heparin to flush out the port in his son’s chest before administering his medication. But early last year, shortly after receiving his drugs, Michael began shaking. His temperature shot up to 106 and Martin rushed him to the hospital where he underwent emergency surgery.

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FDA knew of tainted syringes two years before inspecting plant

The received reports of about debris in syringes filled with heparin and saline distributed by AM2PAT as early as 2005, yet the agency didn’t follow up on those complaints until 2007, after five deaths and hundreds of illnesses were linked to the contaminated syringes, according to the Associated Press.

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