The device involved in the event was not returned.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 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#:19e08a3, 19e25a8 and 19g06s5.
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On (b)(6) 2019, at a hospital in (b)(6), it was reported that supercath5 safety i.V.Catheter was found to be fractured by the confirmation of the device by a nurse because of a removal of the catheter from a patient's body by the patient during an infusion.There was a possibility that the fractured portion fell off when a fixing tape was peeled off, since 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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