BD Plastipak 100ml catheter tip syringes with Luer slip adapters have been recalled after fears of leakage

The government’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert and announced the recall for reportedly defective plastic syringes.

Manufactured by Becton Dickinson, the catheter tip syringe with Luer slip adapters have reportedly failed routine stability tests. Under testing, the syringes can leak through the syringe stopper, rendering administration of medicine inaccurate and unsafe.

The leak is identified in the stopper where medication can leak out of the syringe instead of being administered as intended. The affected syringes have a 5-year expiration date, but can be susceptible to leaking around 2 years after manufacturing.

In the voluntary product recall, Becton Dickinson assured that the medical devices can be used up to those two years. The company is aware that, in extreme cases, the leaking may cause a “delay in therapy, underdosing of the patient or exposure of clinicians or patients to drugs”.

Field safety notice published earlier this year

The recall comes after a Field Safety Notice was published earlier this year in February 2017.

Users and stockists are being asked to acknowledge receipt of the Field Safety Notice before sending the defective products back to the manufacturer for replacement. The syringes are extremely common in medical practice, so all medical staff, physicians and care providers should be made aware of the defect and the subsequent recall. Healthcare institutions who won’t have any of the affected stock are still requested to notify Becton Dickinson that they possess none of the recalled syringes.

The syringes are very popular medical devices in the medical field as it helps physicians administer medication in a safe and accurate manner with little risk of spillage or contamination. The defective stopper that may cause leaks can render the syringe useless in these properties. In the most serious cases, life-saving medication may not be properly administered to a dying patient. The leakage may also spill medication that may save one patients life, but could cause injury to others who come into contact with it. Some medication can be absorbed into the bloodstream by mere contact.

The duty of care

Healthcare institutions have a twofold duty when it comes to providing safety. The patients that healthcare providers attend to must be kept safe and all action must be taken in the interest of their health and well-being. Hospitals and other care institutions needs to ensure they keep up-to-date with the medical device alerts and field safety notices – as they must be aware of whether medical devices which staff use are safe.

Ignoring a defect in a medical device can cause harm and even serious injury to the patient, and possibly the administrating physician.