Model Number 461055E |
Device Problems
Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/14/2022 |
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 the 2nd port on the tube had a strange opening, and did not look normal.The tube was still used in the patient.Additional information received stated the enfit connector detaches from the y port.
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Manufacturer Narrative
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A device history record review could not be performed because a serial number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality prior to the release of product.All tubes must pass a 100% leak testing before being packaged and shipped.Photos were provided for evaluation.The photos show that the enfit connector had detached from the y-port assembly.The manufacturing process of y-port assembly was reviewed.A leak test is performed at the final inspection station and can detect the reported issue.The exact root cause of the reported issue could not be determined.The supplier of the y-port has implemented a corrective action to improve solvent dispensing and the y-port wing to increase the surface area for the bond.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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