Catalog Number 394600 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 the bd connecta¿ stopcock disconnected from the iv set.The following information was provided by the initial reporter: "the connection between the stopcock to iv sets is loss and disconnected.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 04-oct-2022 h6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection and testing of the sample.No defects or abnormalities were observed during inspection and no connection issues were experienced during functional testing.Bd cannot determine the cause of the failure since the defect was not confirmed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch was in compliance with our product specification requirements.
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Event Description
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It was reported that the bd connecta¿ stopcock disconnected from the iv set.The following information was provided by the initial reporter: "the connection between the stopcock to iv sets is loss and disconnected".
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Search Alerts/Recalls
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