Model Number AC0201250 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebv0152 showed five other similar product complaints from this lot number.Device not returned yet.
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Event Description
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It was reported by the facility, that the healthcare professional was performing a training with the device.When the cap was removed the catheter pulled out and remained inside the cap.Device was not used on patient.This file addresses device five of five.
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Manufacturer Narrative
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The initial complaint appeared to be a reportable occurrence.Upon receiving additional information about the event, it was determined that a reportable event had not occurred.A lot history review (lhr) of rebv0152 showed five other similar product complaints from this lot number.Device not returned yet.
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Event Description
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It was reported by the facility, that the healthcare professional was performing a training with the device.When the cap was removed the catheter pulled out and remained inside the cap.Device was not used on patient.This file addresses device five of five.
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Search Alerts/Recalls
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