Catalog Number 383284 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/10/2020 |
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.(b)(4).
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Event Description
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It was reported that the intima-ii y 24gax0.75in mz prn slm npvc experienced a loose end cap.The following information was provided by the initial reporter: the positive pressure connector fell off accidentally during infusion adr# (b)(4).
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Manufacturer Narrative
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H6: investigation summary: 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.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.H3 other text : see h.10.
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Event Description
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It was reported that the intima-ii y 24gax0.75in mz prn slm npvc experienced a loose end cap.The following information was provided by the initial reporter: the positive pressure connector fell off accidentally during infusion adr# (b)(4).
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Search Alerts/Recalls
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