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 05/20/2019 |
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 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 medication was unable to be delivered with a bd ultrasafe x100l png clear nvs stein.The following information was provided by the initial reporter: patient stated that when she pushed the button, the needle was not released and she did not get her injection.
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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 (b)(6) 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 medication was unable to be delivered with a bd ultrasafe x100l png clear nvs stein.The following information was provided by the initial reporter: patient stated that when she pushed the button, the needle was not released and she did not get her injection.
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Search Alerts/Recalls
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