Catalog Number 47439230 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Pma / 510(k)#: k011369, k122558.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that during use of the ultrasafe x100l png clear nvs stein the syringe was not working.The following information was provided by the initial reporter: reporter stated they had issue with "syringe not working¿¿.
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Event Description
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It was reported that during use of the ultrasafe x100l png clear nvs stein the syringe was not working.The following information was provided by the initial reporter: reporter stated they had issue with "syringe not working¿¿.
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Manufacturer Narrative
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H.6.Investigation summary: neither sample nor photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.During the years of investigation of complaints about pre-activated devices several root causes were discovered which were within the customer¿s sphere of influence.H3 other text : see section h.10.
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Search Alerts/Recalls
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