C.R. BARD, INC. (BASD) -3006260740 SITE RITE 8 ULTRASOUND SYSTEM 20MM CUE LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Catalog Number 9770603 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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Event Description
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The probe strain relief has wires exposed.No other information was provided.
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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 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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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 probe strain relief wires exposed was confirmed.The probe strain relief wires are exposed.The top and bottom housings of the probe connector are physically damaged.The strain relief is disconnected from the probe connector housings and there is a cut in the cable jacket.The root cause of the probe strain relief wires are exposed is due to use of the device.H3 other text : evaluation summary findings in h:11.
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Event Description
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The probe strain relief has wires exposed.No other information was provided.
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Search Alerts/Recalls
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