C.R. BARD, INC. (BASD) -3006260740 BD PREVUE II PERIPHERAL VASCULAR ACCESS SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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Model Number N/A |
Device Problems
Poor Quality Image (1408); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
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 will be evaluated.A supplemental will be submitted with evaluation results.
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Event Description
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It was reported the image quality is very poor and below a certain depth is very hard to see.
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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 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 site rite prevue ii was visually inspected upon receipt and was found to be in poor physical condition.The reported issue of image quality is very poor is unconfirmed.The image produced is of similar quality to acceptable examples so the reported issue could not be reproduced.There is no root cause due to the reported issue being unconfirmed.H3 other text : evaluation findings are in section h11.
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Event Description
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It was reported the image quality is very poor and below a certain depth is very hard to see.
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Search Alerts/Recalls
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