Mylan, the drug company that, is on the defensive again. A new report shows a big rise in complaints about the device not working in life-threatening emergencies.
Bloomberg says 228 people this year reported failures of EpiPen, which injects a drug that can stop severe allergic reactions. That's way up from 2012, when just four failures were reported.
Mylan doesn't take issue with the data but said Bloomberg's article is "misleading." It said a rise in reports of failures doesn't necessarily mean a rise in actual failures and suggests heightened attention on the company and increased prescriptions could be to blame, reports CBS News correspondent Tony Dokoupil.
But for those who depend on the device, any failure is unacceptable.
"Watching your child sit there scream to you 'don't let me die' is awful for any parent to have to go through," said Tina Hampton, who has a 6-year-old daughter.
This past spring, her daughter was gasping for breath after an allergic reaction to peanuts. Hampton's moment of panic was made worse after she reached for an EpiPen.
"When I pulled it out, the needle did not go back inside of the EpiPen, It was bent," Hampton said.
It sliced her daughter's leg leaving a scar. She credits a backup EpiPen for saving her child's life.
Bloomberg obtained data from the FDA, linking 228 reports of EpiPen failures to seven deaths and 35 hospitalizations this year. The FDA cautions that with its reporting system, "there is no certainty that the reported event ... was due to the product."
Dr. Scott Sicherer of Mount Sinai Hospital in New York is a pediatric allergy expert.
"It's a very easy device to use, but someone in a panic might use it wrong," Sicherer said of the EpiPen.
He showed us how quickly the EpiPen deploys. Slow-motion gives a better look at how it delivers a dose of epinepherine – just one shot per device. In emergencies, he says some folks mess up holding it the wrong way.
"When they press it, they then get the medication into their thumb," Sicherer said.
Despite the increase in reports of failures since 2012, Mylan said "no changes have been made to the EpiPen device since 2009." The company said they haven't found a "causal connection" between reported patient deaths and the EpiPen.
There was aof some EpiPens earlier this year due to a defective part. But the FDA told CBS News: "We are not aware of defective EpiPens currently on the market and recommend that consumers use their prescribed epinephrine auto injector." As for Hampton, whose EpiPen needle cut her daughter, she's now switched to a competing injector.