Catalog Number 60SP035 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Pma 510(k): additional 510(k): k083641.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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It was reported that the patient's parents could not remove the heat moisture exchanger (hme) from the hub of a portex® bivona® uncuffed pediatric tracheostomy tube.It was noted that the event resulted in "decannulation".No patient injury was reported.See mfr: 3012307300-2017-01052.
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Manufacturer Narrative
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One device was returned for evaluation.Functional testing of the device involved a taper gage check and found the components within dimensional specifications and that the insertion of the connector into the hme filter had no issues.It was indicated that the hme adapter would not separate from the connector if too much force was applied.A review of the device master record was performed and found to be complete.The investigation did not reveal any intrinsic manufacturing defects.Based on the evidence, the root cause was attributed to a user error, due to the user interfacing with the product in a manner inconsistent with the instructions for use.
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Search Alerts/Recalls
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