CARDINAL HEALTH DOBBHOFF 10FR 43IN W STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Model Number 8884711006E |
Device Problems
Difficult to Remove (1528); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2022 |
Event Type
malfunction
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Event Description
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The customer reported that on (b)(6) 2022, nasogastric tube (ngt) was noted to be coiled in patient¿s mouth and was removed.Prior to inserting another dobbhoff (10f), the customer assured that the guidewire was easily able to be extracted.The ngt was placed; however, the guidewire was not able to be pulled out and met with a ton of resistance.They removed the ngt and placed a salem sump instead.There was no 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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Since a lot number was not provided, the device history record review could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A physical sample was not received for the investigation.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
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Search Alerts/Recalls
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