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Catalog Number DL950J |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records was 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.H10: d4: (expiration date: 03/2026).H11: section a: through f: the information provide 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.
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Event Description
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It was reported that prior to an inferior vena cava filter placement procedure, the hook at the tip of the pusher and the hook at the tip of the inferior vena cava filter allegedly had come off.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: additional information was received and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali jugular system products that are cleared in the us.The pro code and 510 k number for the denali jugular system products are identified in d2 and g4.H10: d4 (expiration date: 03/2026), g3.H11: h6 (device).H11: section a through f ¿ the information provide 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.
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Event Description
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It was reported that prior to an inferior vena cava filter placement procedure, the hook at the tip of the pusher and the hook at the tip of the inferior vena cava filter allegedly had come off.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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