Model Number 383313 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Information (3190)
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Event Date 09/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: 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 prior to use it was discovered that the needle is loose with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from (b)(6) to english: at 9 o 'clock on (b)(6) 2019, it was found that needle core loosen before use , so a new indwelling needle was immediately replaced for backup, which did not cause any adverse reactions.
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Event Description
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It was reported that prior to use it was discovered that the needle is loose with a bd saf-t-intima¿ iv catheter safety system.The following information was provided by the initial reporter, translated from chinese to english: at 9 o 'clock on (b)(6) 2019, it was found that needle core loosen before use, so a new indwelling needle was immediately replaced for backup, which did not cause any adverse reactions.
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Manufacturer Narrative
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H.6.Investigation: a device history record review was performed by our quality engineer team for provided lot number 7293902.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported incident and all quality tests were found to be within specification.As a sample was not available for this incident, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be determined.There are current quality controls in place to detect this type of defect during the production process.
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Search Alerts/Recalls
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