Catalog Number 515301 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 the injector of the bd phaseal¿ secondary set drip chamber c60 was difficult to engage, causing a puncture in the diluent bag and the caps to not seal completely.There was no report of exposure, injury, or medical intervention.
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Manufacturer Narrative
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Investigation summary: as neither a sample nor a lot number were provided for evaluation, a complete investigation consisting of a sample analysis and a production history review could not be performed.The secondary set is manufactured at a subcontractor location, but the connector component is manufactured within bd.During the molding and assembly processes, regular inspections are performed to detect faulty product.Investigation conclusion: one complaint was sent to the subcontractor.Based on the information provided the manufacturer concluded that the leak was not cause due to manufacturing process.The information provided is not enough for a more thorough investigation.
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Event Description
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It was reported that the injector of the bd phaseal¿ secondary set drip chamber c60 was difficult to engage, causing a puncture in the diluent bag and the caps to not seal completely.There was no report of exposure, injury, or medical intervention.
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Search Alerts/Recalls
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