CARDINAL HEALTH ENTRFLX 8FR 36INW STYLTY SITE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Model Number 8884720825E |
Device Problem
Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/09/2024 |
Event Type
malfunction
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Event Description
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Customer reports: essentially the patient involved had the nasogastric tube inserted on the (b)(6) 2023 - so it had been in for a few weeks.The patient receives medication & feeds via the nasogastric tube.The night duty nurse had gone to change the patients nappy around 0400 and notice the tip of the ngt poking out of the patients bottom - extremely unusual (given the tube was still in use and aspirating normally).The nurse removed the piece (as shown in the photos) - the patients mother did not want to remove the rest at this time as it is traumatic for the patient.When removed, it appeared the ngt had almost burst/melted away at one end.When the rest of the ngt was removed later that day, you can see the same damage on that end too.Placement confirmed by ph test not xray.Per additional information received on 1/10/23, the detached piece passed through the bowel.There was no further medical intervention, injury or harm reported.
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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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Manufacturer Narrative
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The device history record (dhr) review could not be performed since no lot number was provided from customer complaint report, and no photo/actual sample with an identifiable lot number was received.One (1) picture was submitted for review.The photograph of the product confirms the reported condition.The final part of the tube where the tip of the bolus is included, however it is also observed that the sample could have been broken by an excess of air that caused a balloon to form in the tube.This condition could not have been caused by a manufacturing process and there is no sample returned for testing.The investigation shows that all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.Precautions are listed on the instructions for use ifu)) to avoid occlusions with medicines or food.No corrective actions are planed at this time.The manufacturing plant will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.
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