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 lot numbers listed below that had the possibility to be the same lot number as that involved in the event.Also, the investigation was conducted by reviewing the records of manufacturing processes of the iv catheter with the lot numbers listed below, 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 repeated bending of the catheter occurred during the indwelling because of insufficient fixation of the device to a patient's body.This resulted in a decrease in tensile strength of the catheter to a point where the catheter could not withstand the pull force and fractured.Lot#: 19c23c3, 19d06c5 and 19d16c1.(b)(4).
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On (b)(6) 2019, at a hospital in (b)(6), it was reported that supercath 5 safety i.V.Catheter was fractured when it was pulled out of a patient's body during a procedure.The presence of the fractured portion was not confirmed in the patient's body.There was no reported patient injury as a result of this event.
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