SmartSite (syringes)

2019: A withdrawal of the rejected devices

At the beginning of July, 2019 Becton Dickinson recalled nearly 3000 rejected syringes SmartSite used in intensive care unit of newborns. The Food and Drug Administration (FDA) gave to a response the status I of a class, i.e. problem, the life-threatening patient.

The response was initiated by Franklin Lakes, Becton Dickinson subsidiary company in the State of New Jersey. It urgently recalled 2900 rejected syringes SmartSite which are used together with infusional pumps for introduction of drugs, blood transfusion and its medicines in intensive care unit. The revealed defects formed the basis for a response – syringes passed liquid for a mating ring. As representatives of the company explained, such problem can lead to a delay or interruption of infusion, insufficient introduction of medicines, pollution of the trunk for the entered liquid and to contact of the medic with infuzaty.

Becton Dickinson recalls the rejected syringes which use in intensive care units of newborns

Leak of the entered liquid can arise during infusion or filling, at the same time one drop appears approximately each 10 seconds on an input and/or the output of the trunk from the device of fastening of the filter, representatives of BD explained. They also added that all medical devices affected by a response were manufactured in April, 2018 and extended in the market during the period from May 11, 2018 to September 14, 2018. All of them should be immediately utilized.

Messages about any unfavorable events in connection with the revealed problem did not arrive yet. The company recommends to all buyers to review stock and to utilize all products affected by a response. It is recommended to announce all adverse reactions connected with use of this product in BD and in the regulatory program of tracking of ghost effects MedWatch.^[1]

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