510(k)#: k011369, k122558.Investigation summary: unconfirmed, no sample received.Investigation conclusion: the customer issued a complaint for pre-activated device detected by end user 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.Root cause description: 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.Best practices and guidelines were collected and summarized.Rationale: complaint is unconfirmed.
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It was reported that the ultrasafe x100l png clear nvs stein experienced a broken syringe/pen which was noted during use.The following information was provided by the initial reporter: the consumer explained he received his medication, and when he tried to dispense the medication it got stuck.The needle would not come out, and the medication stayed in the syringe.(no defect could be detected upon sample receipt).
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