Model Number 2420-0500 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.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 a bd alaris pump module smartsite infusion set the tubing had no connector.There was no report of patient impact.The following information was provided by the initial reporter: the primary iv tubing came out of the package without a connector on the patient end.
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Event Description
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It was reported while using a bd alaris pump module smartsite infusion set the tubing had no connector.There was no report of patient impact.The following information was provided by the initial reporter: the primary iv tubing came out of the package without a connector on the patient end.
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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: 09sep2022.H6: investigation summary: one sample was received for quality investigation.The customer complaint of misassembly was verified by visual inspection.Evaluation of the sample received shows that the male luer connector at the end of the assembly is missing.Further evaluation of the tubing where the luer was to be connected indicates that there is no sign of solvent on the tubing.A device history record review for model 2420-0500 lot number 22033263 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2420-0500 lot number 22033219 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set a device history record review for model 2420-0500 lot number 22033264 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set a device history record review for model 2420-0500 lot number 22033214 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set based on the results from the investigation and the description of the events provided by the customer, the root cause for the failure is that the infusion set was packaged without the male luer connector assembled on the infusion set.The manufacturing location was informed of the issue and process improvement steps have been put into place to correct this issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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