Model Number 72213N |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that prior to use with 2 bd alaris¿ secondary set the device was discovered to have a piece missing while in the package.The following information was provided by the initial reporter: it was reported by customer that bd secondary set found broken in package.What component of the tubing set was damaged/broken/missing? the connecting piece is missing.Incomplete manufacturing?.
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Event Description
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It was reported that prior to use with 2 bd alaris¿ secondary set the device was discovered to have a piece missing while in the package.The following information was provided by the initial reporter: it was reported by customer that bd secondary set found broken in package.What component of the tubing set was damaged/broken/missing? the connecting piece is missing.Incomplete manufacturing?.
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Manufacturer Narrative
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The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11-jul-2023.H.6.Investigation summary: one sample was received for quality investigation.The customer complaint of component damage/no leak was verified by inspection.Evaluation of the submitted sample shows that the distal end luer connector is missing.Further inspection of the sample under magnification shows that there is sufficient solvent at the distal end of the tubing for the luer connection, however, the customer had reported that the secondary set was already missing the luer inside the packaging.A device history record review for model 72213n lot number 23019070 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.An investigation at the manufacturing facility determined that the root cause for the issue, seen in the sample submitted, is that formation of gaps would occur during the joining of components by the assembler.A quality alert was created on 13sep2023 and communicated to production personnel to inform of this failure mode and reinforce the correct operation to avoid misassembly of the set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Search Alerts/Recalls
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