C.R. BARD, INC. (BASD) -3006260740 SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE (REFURBISHED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Catalog Number 9770603R |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2024 |
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
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Event Description
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It was reported: the rubber safety cover on the wire cord is already beginning to pull apart and separate from each other.This is a safety issue for us as bare wire is showing through the cover.
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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 service facility for evaluation.During evaluation, the reported issue of the cord is pulling away was confirmed.The probe cable cover is separated from the strain relief on the transducer end.The root cause is use related.H3 other text : evaluation summary findings in h:11.
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Event Description
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It was reported: the rubber safety cover on the wire cord is already beginning to pull apart and separate from each other.This is a safety issue for us as bare wire is showing through the cover.
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Search Alerts/Recalls
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