The device involved in the event was returned.The returned device was examined and the repeatability test (tensile strength testing etc.) was conducted using reserved samples with the same lot number as that involved in the event.Also, the investigation was conducted by reviewing the records of the manufacturing processes of the iv catheter with the same lot number as that involved in the event, and it was confirmed that there were no manufacturing processes that caused or contributed to the event, and there were no manufacturing records of visual inspections that showed the cause of or contribution to the event.Judging from this examination, a possible cause of this fracture is that a patient himself/herself has pulled the device with a force greater than acceptable level.In result, catheter could not endure the tensile strength, then it was broken.Lot#: 23c03s5, 23c06s2 and 23c06sa.
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On (b)(6) 2023, at a hospital in japan, it was reported that supercath5 safety i.V.Catheter was found to be fractured by the confirmation of the device because of the leakage of medical solution from the device during an infusion.The fractured portion was surgically removed from the patient's body.There was no reported patient injury as a result of this event.
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