When medical patients go into the hospital to receive care they rely on the expertise and professionalism of all those working on their behalf--doctors, nurses, aides, and others. Not only that, but patients also rely on the products those professionals use. From the high-tech medical beds to immensely complex surgical robots, medical care today is dependent on the sophistication of many different medical devices.
Unfortunately, at times these products are designed dangerously or there are manufacturing mistakes that put patients at risk.
FDA Catheter Recall
For example, consider a recent recall of certain tracheal tubes by Smiths Medical. The FDA announced the recall in a press released posted to their website last week.
Tracheal tubes are a type of catheter inserted into the trachea (throat) to help a patient breath. There are different types of these tubes, including: endrotracheal tubes (inserted through the mouth), tracheostomy tubes, and tracheal buttons. These tubes can be used in different ways for different patients. In addition to maintaining airways, they can also help deliver medication.
According to the press release announcing the most recent recall, the manufacturing company Smith Medical voluntarily decided to recall a specific type of catheter known as the Portext Uncuffed Pediatrio-Sized Tracheal Tube. The recall affects three different sizes of tubes--2.5mm, 3.0mm, and 3.5mm--manufactured several years ago (before September 2009).
Apparently, the problem with the tubes is that some had internal diameters smaller than indicated on the label. In other words, while indicated at 3.0mm, for example, some tubes diameters were actually not that size. This labeling and/or manufacturing error can cause serious problem for patients. Doctors and nurses working with the defective tubes may have “difficulty passing through or withdrawing the suction catheter.”
Ultimately, catheter errors of this nature are incredibly serious. At the recall notification explains, problems may include the build-up of secretions and the blockage of a patient’s airways. This partial or complete airway obstruction can make it hard for the patient to breathe or for caregivers to ventilate the patient. The recall notice specifically indicates that “there is a reasonable probability of serious injury and/or death
Considering the stakes, it is important for all medical professionals to take appropriate steps to prevent harm. Specifically, the recall notice advises all those who may have received these defective tubes to return all unused products. Caregivers should review the specific list with affected products codes available on the FDA webpage for the situation.
If you or someone that you know may have been injured as a result of problems with a tracheal tube, please contact our malpractice lawyers today. We work with families in many different settings, including dangerous medical devices. The civil law specifically provides avenues for those harmed in this way to recover damages for their losses.