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Model Number DL900J |
Device Problems
Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2025).
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Event Description
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It was reported that prior to a filter placement procedure, the device allegedly partially deployed.The procedure was completed using another device.There was no patient contact.
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Event Description
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It was reported that prior to a filter placement procedure, the device allegedly partially deployed.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: 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: d4 (expiry date: 01/2025), g3.H11: g1, h6 (device).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.H3 other text : device not returned.
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Search Alerts/Recalls
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