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Model Number I300F85 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2022 |
Event Type
malfunction
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Event Description
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As reported, during a procedure in the patient with this introducer sheath, some whitish material came out during flushing prior to insertion.There was no allegation of patient injury.Follow up has started for the device return for evaluation.
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Manufacturer Narrative
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The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.
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Manufacturer Narrative
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One introducer sheath was received by our product evaluation laboratory for a full examination.The reported event of 'white material came out during flushing' could not be confirmed.As received, no material dislodged from the introducer while flushing.The internal components were examined and found to be in good condition.However, when the hemostasis valve was disassembled from sheath hub, flash material was observed on the threaded area of the sheath hub.Flash was measured to be 0.06" in length being out of specifications.No other visible abnormality was observed on sheath body.Additionally, the manufacturing records were reviewed and there is no indication of a related nonconformance, all process parameters were met and inspections passed successfully.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Manufacturer Narrative
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Further investigation was performed by the engineers at the manufacturing site.The flash condition was related to the flashing inspection during the manufacturing process.Therefore, the unit was not sent to perform a second deflashing process.An acknowledgment was provided to the manufacturing personnel regarding this condition.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of this monthly review.
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Search Alerts/Recalls
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