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Model Number 9770086R |
Device Problem
Failure to Align (2522)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been received by the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.Device has not been received, at this time.
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Event Description
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Per clinical tech services, alignment is 'off'.
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Manufacturer Narrative
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H11:section a through f - the information provided by bd 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 bd.The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined, that the information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore, this event is deemed not reportable per 21 cfr part 803.
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Event Description
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Per clinical tech services, alignment is 'off'.
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Search Alerts/Recalls
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