TOGO MEDIKIT CO. LTD. SUPERCATH 5; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Catalog Number SP200-01 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 08/07/2020 |
Event Type
Injury
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Manufacturer Narrative
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A picture of the device involved in this event was provided.Photos of the device provided were investigated.A reproducibility test (such as a tensile strength test) was performed using stored sample specimens with the following lot numbers that may have the same lot numbers as those included 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 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.Alternatively, the patient may have pulled out the external needle and chewed off the catheter part by himself due to dementia.Lot#:20b13s3, 20c04b1 and 20e22sa.
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Event Description
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On (b)(6) 2020, 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 because of the leakage of medical solution from the device 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.Alternatively, the patient may have pulled out the external needle and chewed off the catheter part by himself due to dementia.There was no reported patient injury as a result of this event.
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