Catalog Number 383403 |
Device Problems
Fluid/Blood Leak (1250); Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/05/2018 |
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 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 nurse found a kink in the bd intima ii¿ iv catheter near the pinch clamp.On the second day of infusion the nurse noticed normal saline leak from the kinked location.Found during use.No reports of serious injury or medical intervention noted.
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Manufacturer Narrative
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Investigation summary: a sample was received for the purpose of our investigation.Bd was able to observe the reported failure mode in the sample provided.The tubing of the returned sample was broken about 70mm away from the pp luer.The damage is triangular in shape and the extension tubing had compression marks.Because the unit behaved as expected for the first two days the root cause could not be finalized.The batch record was reviewed, no related abnormalities were found.Investigation summary: the unit behaved as expected for the first two days the root cause could not be finalized.
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Search Alerts/Recalls
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