Catalog Number ASK-05500-NRON |
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 06/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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The filter got detached during use on a patient.Therefore, the catheter and the filter were replaced with a new kit.According to the user, the rotatable collar was not detached from the filter; it seemed that the filter itself was loose so that rotated to be detached.Also, the same issue had occurred once in april and 4 times in may.(however, they had not been reported to teleflex (b)(4) as complaints.).
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Manufacturer Narrative
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(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the flat filter with no relevant findings.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was returned for analysis.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the flat filter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
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Event Description
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The filter got detached during use on a patient.Therefore, the catheter and the filter were replaced with a new kit.According to the user, the rotatable collar was not detached from the filter; it seemed that the filter itself was loose so that rotated to be detached.Also, the same issue had occurred once in april and 4 times in may.(however, they had not been reported to teleflex japan as complaints.
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Search Alerts/Recalls
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