Unomedical reference number (b)(4).Event occurred in canada.On 08-oct-2023, it was reported that the patient's infusion set's tubing (including the cannula) came apart close to the site, but the site stayed on her arm.The issue occurred while she was sleeping.Moreover, the site location was patient's arm, and the infusion set was used for three days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.According to the complaint investigation performed on the returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information was available.
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