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 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 01/10/2024 |
Event Type
malfunction
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Event Description
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It was reported the customer's probe was connected to the unit and it was observed that that the screen was very dark.
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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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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Manufacturer Narrative
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H11: 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 cue probe was visually inspected upon receipt and was found to be in good physical condition.The reported of poor image is confirmed.The customer probe was connected to the unit and it was observed that the screen was very dark an image was barely produced.The root cause is due to an internal failure within the probe.
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Event Description
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It was reported the customer's probe was connected to the unit and it was observed that the screen was very dark.
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Search Alerts/Recalls
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