Catalog Number 385102 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 03/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd q-syte extension set 15 cm (6 in) 0.34 ml micro bore leaked from the top of the septum the following information was provided by the initial reporter: "the patient was admitted due to prostatic hyperplasia, and was given intravenous infusion.At 9:00 on the morning of (b)(6) 2020, the responsible nurse found a little bleeding in the diaphragm during the routine rounds of the ward, and immediately gave the replacement without adverse consequences to the patient.".
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Manufacturer Narrative
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H.6.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.
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Event Description
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It was reported that bd q-syte extension set 15 cm (6 in) 0.34 ml micro bore leaked from the top of the septum.The following information was provided by the initial reporter: "the patient was admitted due to prostatic hyperplasia, and was given intravenous infusion.At 9:00 on the morning of (b)(6) 2020, the responsible nurse found a little bleeding in the diaphragm during the routine rounds of the ward, and immediately gave the replacement without adverse consequences to the patient.".
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Search Alerts/Recalls
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