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 study, the probable cause of this fracture is that the patient fell from the bed and pulled the device with a force that exceeded the acceptable level.In result, catheter could not endure the tensile strength, then it was broken.Lot#:19h22s3, 19h22s4 and 19h26s2.
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On (b)(6) 2019, at a (b)(6) hospital found that the patient had fallen from bed during a supercath 5 safety iv infusion, and the device was found to be damaged by a nurse, confirming the device.The fracture was found under the patient's bed.There was no reported patient injury as a result of this event.
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