Model Number 11582774 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd sec 20dp no ports w/hanger dehp free the components were separated.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the "tubing was not connected to chamber".Verbatim: event description: bedside rn opened secondary iv tubing set and noticed tubing was not connected to chamber.
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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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Event Description
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It was reported while using bd sec 20dp no ports w/hanger dehp free the components were separated.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the "tubing was not connected to chamber".Verbatim: event description: bedside rn opened secondary iv tubing set and noticed tubing was not connected to chamber.
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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: 09-aug-2022.H6: investigation summary the customer reported a separation and returned one used 11582774.The sample was separated below the drip chamber, and the complaint is verified.The root cause was found to be traced to the assembly process.Manufacturing will review operations to mitigate the risk of this issue happening again.Device history record review for model 11582774 lot number 22049332 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 26apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Search Alerts/Recalls
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