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 06/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.Pma/510(k)#: k011369, k122558.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 ultrasafe passive¿ x-series needle guard syringe was unable to deliver medication.This was discovered during use.The following information was provided by the initial reporter: when button pushed the needle was not released and no medication came out.
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Manufacturer Narrative
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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.It should be noted that tests performed by bd tatabánya during production controls are related to the assembled device, without using syringe and plunger rod.Testing of combination product is out of scope for safety device manufacturing.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.
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Event Description
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It was reported that bd ultrasafe passive¿ x-series needle guard syringe was unable to deliver medication.This was discovered during use.The following information was provided by the initial reporter: when button pushed the needle was not released and no medication came out.
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Search Alerts/Recalls
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