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Model Number 9770603 |
Device Problems
Signal Artifact/Noise (1036); Poor Quality Image (1408)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 device has not been received by the manufacturer for evaluation.A history review of serial number asenag026 showed no other similar product complaint(s) from this serial number.
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Event Description
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Per tm, reported a ¿grainy image¿ that continued to get worse as time progressed in the procedure.It looks like there is more white artifact than normal.This resulted in an extra poke for the patient because the needle tip was not visible on the screen.
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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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of a ¿grainy image¿ that continued to get worse as time progressed in the procedure was unconfirmed; the probe functions normally.Could not duplicate the problem.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
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Event Description
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Per tm, reported a ¿grainy image¿ that continued to get worse as time progressed in the procedure.It looks like there is more white artifact than normal.This resulted in an extra poke for the patient because the needle tip was not visible on the screen.
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Search Alerts/Recalls
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