Catalog Number 394600 |
Device Problems
Leak/Splash (1354); 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 12/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that 15 bd connecta¿ stopcocks experienced a loose connection.The following information was provided by the initial reporter: the connection on the side of the venflon simply jumps back, in the best case a leak occurs and in the worst case the device simply disconnects from the patient and the venflon remains open.
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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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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-jan-2023 h6: investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no abnormalities or defects on the returned sample.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed by the returned sample analysis.Production records were reviewed, and this batch was in compliance with our product specification requirements.See h10.
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Event Description
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It was reported that 15 bd connecta¿ stopcocks experienced a loose connection.The following information was provided by the initial reporter: the connection on the side of the venflon simply jumps back, in the best case a leak occurs and in the worst case the device simply disconnects from the patient and the venflon remains open.
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Search Alerts/Recalls
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