[185983574]
Unomedical reference number (b)(4). Event occurred in the united states. The patient reported that he faced a bent cannula issue and the infusion set being stuck inside of the serter walls, so insulin did not flow. Reportedly, the inside walls caused infusion set to stick to it. It was also stated by the patient that the serter did not show signs of physical/cosmetic damage. Moreover, he cleaned the serter after every 3-4 uses. Further, while he inserted the infusion set (needle- blue plunger) in, it stuck inside the serter, but he and his wife thought it was in there. Subsequently, on (b)(6) 2020 at 3:00 pm, he was admitted in the hospital as his blood glucose level was over 1200 mg/dl and he experienced diabetic ketoacidosis. Moreover, the infusion set was last changed on (b)(6) 2020 at the nighttime. During hospitalization, he received a drip intravenously, as he had a intravenous port on his chest that's how they gave the insulin. On 15-mar-2020 at 5:00 pm, he was released from the hospital. Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length. Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly. No further information available.
Patient Sequence No: 1, Text Type: D, B5