Catalog Number 67PFPS50 |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2024 |
Event Type
Injury
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Event Description
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It was reported, that the tracheostomy tube became damaged after 147 days of use.With a hole forming at the junction of the outer cuff balloon.And the thin tube connecting it to the cuff's adjacent cuff.This resulted in leakage of the blocking solution.The customer had a replacement cannula, but expressed a desire to replace the defective product.There was patient involvement.And no patient harm/adverse event reported.
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Manufacturer Narrative
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E1: initial reporter phone#: (b)(6) investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.
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Manufacturer Narrative
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One device was received for investigation.It was identified that the sample has conditions of use, the inflation line has a hole at the joint of the tube and the pilot balloon.The reported failure mode was confirmed.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
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Search Alerts/Recalls
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