Infant Medicine Feeder Delivers Incorrect Dose

Main Category: Pediatrics / Children's Health
Also Included In: Medical Devices / Diagnostics
Article Date: 18 Jun 2009 - 5:00 PST

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Parents of babies and young children are being urged to stop using the 'First Steps' medicine feeder range manufactured by RSW International Ltd after the Medicines and Healthcare products Regulatory Agency (MHRA) uncovered potential safety and quality concerns.

The MHRA was recently alerted to the product being distributed nationwide and sold for one pound in discount retail outlets, and on eBay, after a six month old baby was admitted to hospital in the North West from an overdose while using the device.

RSW International have recalled all remaining stock, however, parents may still have this product in their home.

MHRA Director of Device Technology and Safety, Clive Bray, said he "strongly advised" people to stop using these medicine feeders which are marketed for the administration of liquid medicines to babies and young children.

"There is no evidence that the safety, quality or performance of this product has been assessed to the current standard," he said.

"The product could pose a potential risk to babies or young children as the measuring scale is confusing and could be inaccurate.

"This may have caused the reported overdose and we are strongly advising parents to stop using, and dispose of this product."

Notes

1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. http://www.mhra.gov.uk

Source
MHRA