SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
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Model Number 198-32L |
Device Problems
Leak/Splash (1354); Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2019 |
Event Type
malfunction
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Event Description
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Information was received that while a smiths medical endotracheal tube was in use with a patient, the device was noted to be leaking air from the bronchial cuff.The cuff was noted to be damaged.No patient injury resulted.
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Manufacturer Narrative
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One portex® endobronchial tube was returned for analysis in used condition.Upon visual inspection of the returned sample; no discrepancies were found.A syringe was used to inflate the cuff of tube; leakage was observed coming from the small tear in the blue cuff.Relevant documents were reviewed and deemed adequate.Training records, leak testing procedure, and the production line were reviewed; no discrepancies noted.Leak testing was performed on 32 units from the production floor; no discrepancies or damage were detected.Instructions for use (ifu) were reviewed and noted the following: "cuff leaks that are detected immediately following tube placement are usually due to cuff nicks from teeth or instrumentation during intubation." based on the evidence, the complaint is confirmed.However, the root cause is unknown.It is stated that the most probable root cause is that the cuff become damaged after it left the shm facilities due to the product is 100% leak tested under water.
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