Model Number 67NFPS35 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Customer contact phone number: (b)(6).Device evaluation in progress.
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Event Description
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It was reported that the customer received a defective bivona tracheostomy tube.No patient injury or complications were reported in relation to this event.
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Manufacturer Narrative
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Returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed.No fault found.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
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Event Description
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3/5 reference (b)(6) for all related complaints and attachments.Defective trach.First one was documented in (b)(6).
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Search Alerts/Recalls
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