Catalog Number 306546 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 posiflush¿ ns filled syringe had restricted plunger movement.No serious injury or medical intervention was reported.
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Event Description
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It was reported that bd posiflush ns filled syringe had restricted plunger movement.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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One sample unit belonging to lot number 7110587 was received for evaluation by our quality engineer team.Upon visual inspection of the sample, plunger resistance was identified.A device history record review for lot number 7110587 revealed one non-conformance during the production process that may have contributed to this incident.There was a recorded intermittent issue with the hosing in the manufacturing machinery at the time of this lot's production.Product associated with this defect was held for inspection and all affected material should have been rejected to scrap.It is possible that the product reported within this incident went undetected.A correction has been made to the silicone supply hosing machinery within the designated fill room to prevent this issue from reoccurring.Complaints received for this device and defect will be monitored by our quality team for emerging trends.
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Search Alerts/Recalls
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