Catalog Number 381012 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2021 |
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 that blood leaked from the bd insyte¿ autoguard¿ bc shielded iv catheter when retracting the needle, and saline leaked when starting the infusion.This happened with 2 separate catheters.The following information was provided by the initial reporter, translated from (b)(6) to english: "when retracting the needle after catheter placement, blood leakage was observed.After that, when starting the infusion, saline leakage was also observed.".
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used catheter adapter with its original packaging and five photos.Through visual/microscopic examination, the unit revealed that the septum had been actuated.Once the septum is actuated the flow path is opened and cannot be closed; leakage beyond the septum may occur ten seconds after activation if a secure connection is not made per the ifu.Since the unit had been used and actuated, testing for leakage beyond the septum could not be performed.Therefore, the septum was microscopically inspected for damage that could lead to leakage.It was noted that septum slit was partially open due to dried media preventing the septum from returning the to resting closed position.This could have caused leakage but no visible defects were observed to confirm leakage beyond the septum.The catheter adapter assembly was also tested for any leakage from the luer or catheter tubing once a connection was made.Visual inspection of the adapter did not find any damage.The device was then tested for leakage and no leakage was observed.Bd was unable to confirm the reported defects.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 that blood leaked from the bd insyte¿ autoguard¿ bc shielded iv catheter when retracting the needle, and saline leaked when starting the infusion.This happened with 2 separate catheters.The following information was provided by the initial reporter, translated from japanese to english: "when retracting the needle after catheter placement, blood leakage was observed.After that, when starting the infusion, saline leakage was also observed.".
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Search Alerts/Recalls
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