Model Number 383312 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/04/2019 |
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.(b)(4).
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system needle was loose and affected the insertion.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the indwelling needle was used to prepare the needle for the patient's intravenous infusion, it was found that the needle tip could not be fixed and moved up and down, affecting the needle insertion.The second inspection of the indwelling needle showed that the core of the indwelling needle was bent and could not be pulled out".
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system needle was loose and affected the insertion.The following information was provided by the initial reporter, translated from chinese to english: "when the indwelling needle was used to prepare the needle for the patient's intravenous infusion, it was found that the needle tip could not be fixed and moved up and down, affecting the needle insertion.The second inspection of the indwelling needle showed that the core of the indwelling needle was bent and could not be pulled out".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 8299697.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
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Search Alerts/Recalls
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