Model Number IPN028484 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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In the emergency department and the pulmonology plant of the (b)(6) hospital it has been detected 6 times on 6 different patients since (b)(6) 2021 that the connection of the tube with the pleur-evac rubber is not watertight leading to the leaks in the chamber and event exit of pleural fluid trough the connection.This has generated errors in the diagnosis of the evolution of the patient's pulmonary pathology (detecting a non-real-leak) and causing late withdrawal of the thoracic tube, increasing the days of hospitalization, in addition to a possible risk of infection since not being properly sealed is a gateway to microorganisms.
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Event Description
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In the emergency department and the pulmonology plant of (b)(6) hospital it has been detected 6 times on 6 different patients since august 2021 that the connection of the tube with the pleur-evac rubber is not watertight leading to the leaks in the chamber and event exit of pleural fluid trough the connection.This has generated errors in the diagnosis of the evolution of the patient's pulmonary pathology (detecting a non-real-leak) and causing late withdrawal of the thoracic tube, increasing the days of hospitalization, in addition to a possible risk of infection since not being properly sealed is a gateway to microorganisms.
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Manufacturer Narrative
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(b)(4).The device history record of batch number 74c2100034 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Manufacture date:2021-03-03, expiration date:2024-02-28.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.
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Search Alerts/Recalls
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