SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOBRONCHIAL TUBE; TTUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATIO
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Model Number 198-35L---802 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Month and year have been provided, day in unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Event Description
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It was reported that during the pre-use check, the customer noticed air was unable to be put in the blue cuff.No patient injury reported.No additional information is available for this complaint.
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Manufacturer Narrative
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H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Two (2) photos were provided and reviewed as part of the device analysis.Photo one showed an endobronchial tube next to its original packaging, the whole device was visible; no damage or dysfunctional conditions was observed.Photo two showed a close-up of the union between the bronchial inflation line and endobronchial tube where itwas observed to be occluded.One product was returned and visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.The join between the bronchial inflation line and endobronchial tube was observed to be occluded.No other damage or other dysfunctional conditions that could cause the reported failure were observed.The product was tested for cuff functionality by connecting the bronchial inflation pilot balloon to air and the cuff was attempted to be inflated.The bronchial inflation pilot balloon inflated as intended, but the cuff did not inflate fully confirming the complaint.A root cause was occlusion due to excessive solvent caused by failure to properly follow manufacturing procedure.A device history record (dhr) review showed no discrepancies or nonconformance's during the manufacturing of the reported lot number.Awareness notification was made to production personnel to explain the importance of adhering to, and following, procedure.
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