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 02/19/2020 |
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.Based on the information obtained from the investigation of actual product and the interview with the medical institution, it was identified that the possible cause of this damage is the event that the catheter portion of outer needle was accidentally cut when the tape securing the outer needle was cut with scissors to remove from patient.Lot#: 19i19c4.
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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 fractured when it was pulled out of a patient's body during a procedure.The fractured portion was soon removed from the patient's body by a nurse.There was no reported patient injury as a result of this event.
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