Model Number 2002-300 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2022 |
Event Type
malfunction
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Manufacturer Narrative
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On completion of the investigation a follow up report will be submitted.
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Event Description
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When the patient got out of bed and moved around after the operation, the connect site between the chest drainage and the tissue cracked.Then the doctor changed another one instead.
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Manufacturer Narrative
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It was reported that the catheter connecting the drain to the patient cracked near its connection to the drain.When follow-up information was requested, the customer reported that the catheter was a local brand (in china) and the size was 16 fr.They confirmed that there was no damage to the drain and they did not report any malfunction other than the physical damage to the catheter.Based on the details provided by the customer and the information reviewed during the investigation, it cannot be confirmed that the device was non-conforming to it's specifications.The information provided by the customer indicates that the device was used with a smaller catheter than it is recommended for and they confirmed that there was no malfunction with the drain.Therefore, the root-cause of this issue is operational context.The device history record was reviewed and found no nonconformities or anomalies in its manufacturing.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.A complaint history review was completed which found no related complaints.A review of ncrs and capas were able to rule out any related issues and there were no other complaints received for the affected lot.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.H3 other text : device not available for return.
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Event Description
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Additional information reported stated that the drain was functioning properly before the event occurred.
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Search Alerts/Recalls
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