Y S R PLASTICS INDUSTRIES LTD ADULT ANESTHESIA BREATHING CIRCUIT, 4M, DISPOSABLE, FOR IVENTTM; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number M1173406 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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At this time, vyaire has not received the suspect device/component for evaluation.If additional information becomes available, it will be submitted in a follow up report.
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Event Description
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The customer reported that the circuit passed pre-procedural testing.However, while in use on the patient, it failed and the doctors had to manually ventilate the patient.There was no known impact to the patient.
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Manufacturer Narrative
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Results of investigation the component supplier performed an investigation.In-house produced product passed testing at 100%.Representative samples were received from the customer.One sample was correct and another sample examined failed.It was determined this failure was human error that occurred within the supplier's manufacturing facility.Refresher training for the team was conducted.Refinement has been done to definte control processes with an emphasis on strict testing and double checking prior to packaging.Additionally the supplier opened a capa.Any additional information that becomes available will be updated with a supplemental report.
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Search Alerts/Recalls
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