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 07/10/2019 |
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 lot number 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 number 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 catheter has kinked and pulled during removal of a dressing material or a fixing tape for securing a catheter or an infusion line.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.Lot#: 19d11b7.(b)(4).
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Event Description
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On (b)(6) 2019, at a hospital in (b)(6), it was reported that supercath 5 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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Search Alerts/Recalls
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