CARDINAL HEALTH DOBBHOFF 12FR 43IN W STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Model Number 8884711253E |
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 07/13/2022 |
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 the guidewire from dobbhoff fails to be pulled out by registered nurse (rn) and when the surgeons tried to pull it out, they pulled the dobbhoff out with bent guidewire.Additional information was received from the customer and stated that the definite lot number is unknown, as the product packaging was discarded.There was no patient harm reported.
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Manufacturer Narrative
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A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.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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