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.Judgment from the test, a possible cause of this damage is that the patient pulled by body movement during the infusion, or that the nurse pulled the outer needle with more force than allowed.As a result, the catheter broke to the point where it could not withstand the tensile force.Also, because the patient had delirium, it is possible that the patient pulled out the external needle himself.Lot#: 20j13bd, 20j16c6 and 20j22b6.
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On (b)(6) 2021, at a hospital in (b)(6), it was reported that supercath5 safety i.V.Catheter was fractured when it was pulled out of a patient's body during a procedure.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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