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
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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It was reported strain relief wires exposed.No other information was provided.
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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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Event Description
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It was reported strain relief wires exposed.No other information was provided.
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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 at the strain relief was confirmed.The connector end of the probe is disconnected from the connector housing.The root cause is use related.
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Search Alerts/Recalls
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