TOGO MEDIKIT CO., LTD. SUPERCATH 5; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Catalog Number SP208-01 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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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#: 22l21b7, 23a27b2 and 23b02b2.
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Event Description
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On (b)(6) 2023, it was reported that at a japanese hospital, when all the fixing tape of the indwelling vein needle that had secured the venous channel on february 20 was removed in order to reapply it, the indwelling vein needle supercath5 safety i.V.Catheter was found to be fractured upon confirmation of the device.It was confirmed that the damaged part had fallen onto the bed and was not left behind in the body.There was no reported patient injury as a result of this event.
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