Health Canada — Medical Devices · Canada · 2019-04-29 · Type II
As described by Health Canada — Medical Devices: BACTISEAL EVD Catheter Set, CODMAN Peritoneal Catheter, Ventricular and Peritoneal Catheter Set, CODMAN Ventricular Catheter with BACTISEAL (2019-03-14)
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Reported risk: Precaution was added to the instructions to inform customers to only use sterile water or normal saline to immerse the bactiseal catheter as other solutions are not recommended and may cause precipitation and consequent adverse effects (e.g., catheter occlusion, hydrocephalus). The precaution also advised customers to keep the time the bactiseal catheter immersed in sterile water or normal saline to a minimum (i.e., seconds) to reduce the risk of introducing infectious agents.
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