Catalog Number 47439230 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The date received by manufacturer has been used for this field.(b)(6).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 a bd ultrasafe passive¿ x-series needle guard syringe malfunctioned when the spring ejected from under the needle when pushing the medication down.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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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.
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Event Description
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It was reported that a bd ultrasafe passive x-series needle guard syringe malfunctioned when the spring ejected from under the needle when pushing the medication down.There was no report of exposure, serious injury or medical intervention.
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Search Alerts/Recalls
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