C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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Event Description
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It was reported scratch on the probe causing imaging issues.
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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 returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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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 poor image was confirmed.The site rite 8 probe was visually inspected upon receipt and was found to be in poor physical condition, the probe has a black spot on the image.The root cause of a black spot on the image is due to scratch on the tip of the probe.
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Event Description
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It was reported scratch on the probe causing imaging issues.
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Search Alerts/Recalls
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