Catalog Number 395000 |
Device Problems
Complete Blockage (1094); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/29/2021 |
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 when using the bd connecta white 360deg shelf 100ea india, the device experienced leakage, and flow issues.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: while they were trying to flush, fluid leaking observed at the connection site of cannula and connecta.Back flow seen in connecta despite locking.
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue was not confirmed upon inspection of the photo.In order to confirm the reported failure, a physical sample is needed for the investigation.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported when using the bd connecta white 360deg shelf 100ea india, the device experienced leakage, and flow issues.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: while they were trying to flush, fluid leaking observed at the connection site of cannula and connecta.Back flow seen in connecta despite locking.
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Search Alerts/Recalls
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