C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Catalog Number 9770501 |
Device Problems
Break (1069); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2024 |
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 returned to the manufacturer for evaluation.H3 other text : no device returned for evaluation.
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Event Description
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The probe cord is damaged and has wires exposed.
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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 the probe cord is damaged and has wires exposed was confirmed; the probe cable sleeve is pulling away from the strain relief.The root cause of the reported failure was identified as a use-related adhesive failure.H3 other text : evaluation summary findings in h:11.
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Event Description
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The probe cord is damaged and has wires exposed.
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Search Alerts/Recalls
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