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 09/20/2021 |
Event Type
Injury
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Event Description
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On (b)(6) 2021, 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 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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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 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.Based on the information that the patient has dementia and has a history of self-extraction several times in the past, it is possible that the patient pulled the mantle needle out by himself due to repeated bending of the catheter.Lot#: 21h31ba.
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Event Description
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On (b)(6) 2021, 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 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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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 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.Based on the information that the patient has dementia and has a history of self-extraction several times in the past, it is possible that the patient pulled the mantle needle out by himself due to repeated bending of the catheter.Lot#: 21h31ba.
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