Bayer—Source Administration Sets Used with Medrad Intego PET Infusion Systems: Insertion of Needle May Generate Particulates in Vials

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In a November 4, 2016, Urgent Medical Device Field Safety Corrective Action letter submitted by an ECRI Institute member hospital, Bayer states that particulates may be generated when the tip of the needle of the above administration sets is pushed through the rubber septum of the radiopharmaceutical (RP) vials. Injection of particulates into a patient, depending on the size and the patient's medical condition, may result in infection, tissue damage or death, swelling, or other serious adverse events. Bayer also states that it has received no reports of...