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Catalog Number UNKNOWN FILTER |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a filter placement procedure in supine position via jugular venous approach, the filter was allegedly broken.Reportedly, the filter recovery kit was withdrawn, and the filter was grabbed with a catcher.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.
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Event Description
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It was reported that during a filter placement procedure in supine position via jugular venous approach, the filter was allegedly broken.Reportedly, the filter recovery kit was withdrawn, and the filter was grabbed with a catcher.There was no reported patient injury.
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Manufacturer Narrative
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H10: additional information was received and there is no alleged deficiency or malfunction with the product.This report is no longer being considered a complaint file and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H11: section a through f ¿ the information provided by bd represents all 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.Device not returned.
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Search Alerts/Recalls
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