Model Number 8884721252E |
Device Problem
Difficult to Remove (1528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported they inserted a nasogastric tube at 3:00 am.The feeding tube was checked at 6:00 am.Mandrin (guidewire/stylet) removal impossible.The feeding tube had to be removed and a new feeding tube was placed.No patient injury reported.
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Manufacturer Narrative
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The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed since no sample or photos were returned for evaluation.It was reported that the device was discarded.Based on the available information, the reported issue could not be confirmed.No corrective and preventive actions are required at this time as the reported issue was not confirmed.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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