Model Number 20350E |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd alaris smartsite low sorbing extension set the tubing was kinked and there was discoloration.There was no report of patient impact.The following information was provided by the initial reporter: tubing kinked and discolored.
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 07-feb-2023.H6: investigation summary: thirty three samples were received for quality evaluation.The customer complaint of tubing kinked was verified by inspection.The thirty three samples were initially visually inspected for kinks throughout the tubing assemblies.Four samples of the thirty-three samples submitted showed signs of kinking in the tubing.Further examination of the samples show that the kinks are located on the tubing close to the connection ports of the in-line filters.The samples were connected to a syringe and fluid was pushed through each of the samples with kinks in the tubing.The extension sets did not slow down the affect the ability for fluid to flow through each of the samples.The customer complaint of cosmetic issues was not verified by visual inspection.There was no evidence of discolored components or tubing in the samples received.A device history record review for model 20350e lot number 22099098 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing location has been made aware of the failure and further investigation was conducted to determine the root cause of the kinking.During the investigation it was determined that excess solvent was observed when attempting to replicate the failure.Additionally, the equipment used to expand the tubing had an issue with the tube expander causing the tubing to not be inserted into to sleeve correctly, leaving gaps in the construction, allowing for kinking to occur.A quality alert was generated to prevent this defect and updates to the assembly process have been implemented to correct the issue for future production.A root cause for the customer complaint of cosmetic issue could not be determined because the failure mode could not be verified.
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Event Description
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It was reported while using bd alaris smartsite low sorbing extension set the tubing was kinked and there was discoloration.There was no report of patient impact.The following information was provided by the initial reporter: tubing kinked and discolored.
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Search Alerts/Recalls
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