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Model Number DL900F |
Device Problems
Difficult or Delayed Positioning (1157); Malposition of Device (2616); Positioning Problem (3009)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
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 will 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.(expiration date: 11/2024) device not returned.
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Event Description
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It was reported that during a filter placement procedure via the right femoral vein, the filter allegedly got stuck in the catheter and difficulty to deploy.It was further reported that the filter was unable to release from the delivery sheath; however, physician used the pusher forcefully to get the filter deployed and noticed that the filter was found to be tilted inside the patient.There was no reported patient injury.
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Event Description
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It was reported that during a filter placement procedure via the right femoral, the device allegedly got stuck in the catheter during deployment.It was further reported that the filter was allegedly had difficult to deploy and noted to be tilted inside the patient.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported difficult or delayed positioning and positioning problem of the filter could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 11/2024), g3, h6 (method).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.
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Search Alerts/Recalls
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