C.R. BARD, INC. (BASD) -3006260740 SITE RITE 8 20MM CUE LINEAR PROBE (REFURBISHED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problems
Poor Quality Image (1408); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.H3 other text : device not returned.
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Event Description
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It was reported black lines on images.Verified other probes produce normal images.
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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 device was returned to the service facility for evaluation.During evaluation, the reported issue of black lines on images.Verified other probes produce normal images was confirmed.The probe image has a black spot on the left side of the image.The root cause is due to an internal failure if the probe.H3 other text : evaluation summary findings in h:11.
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Event Description
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It was reported black lines on images.Verified other probes produce normal images.
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Search Alerts/Recalls
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