Catalog Number 383005 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/09/2020 |
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.Fda device problem code:(b)(4).Fda patient problem code: (b)(4).
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from chinese to english: "on 10-9 after successful puncture with indwentric needle, the leakage on the side of the indwentric needle heparin cap was found and replaced immediately".
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked during use.The following information was provided by the initial reporter, translated from chinese to english: "on 10-9 after successful puncture with indwentric needle, the leakage on the side of the indwentric needle heparin cap was found and replaced immediately.".
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Manufacturer Narrative
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H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.
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Search Alerts/Recalls
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