Unomedical reference number (b)(4).Event occurred in (b)(6).On 24-dec-2020, the patient reported that the infusion set's tubing detached at the tubing connector.The patient stated that she had a blockage at the tubing connector, and she had to change the entire infusion set.Moreover, the patient had not used the infusion set.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.No further information available.
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On 08-mar-2021: follow up information was submitted to update the awareness date.Also, a visual inspection and static pull of tubing-tubing connector test were performed on the returned used device (1 set), it was found that all the test results were within specifications.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2020, the patient reported that the infusion set's tubing detached at the tubing connector.The patient stated that she had a blockage at the tubing connector, and she had to change the entire infusion set.Moreover, the patient had not used the infusion set.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.No further information available.
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