Model Number 8884711006E |
Device Problems
Difficult to Remove (1528); 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 12/19/2022 |
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 that when the nurse unscrewed the feeding tube from the catheter, the connector tip came off of the feeding tube.The nurse had to use force to unscrew the feeding tube which was stuck in the connector.Per additional information received, the nurse put the device back in and the tube was still permeable and functional.There was no impact to the patient.
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Manufacturer Narrative
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Section h6.Medical device problem code for ¿difficult to remove¿ was selected in error.
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Manufacturer Narrative
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The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on august 19, 2020.The device was not received for evaluation, but five photos were provided, and the reported condition has been confirmed.A corrective and preventative action has been initiated to address the reported issue.
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Search Alerts/Recalls
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