Date of event: unknown.Initial reporter phone #: unknown.Pma / 510(k)#: k011369, k122558.Investigation summary: 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.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 during use it was discovered that the needle cap was pushed into the barrel, and unable to be removed, the plunger was also difficult to move with a bd ultrasafe x100l png clear nvs stein.The following information was provided by the initial reporter: faulty syringe/product complaint.Needle cap was pushed into the barrel of the syringe, and the cap was not able to be removed.The plunger could not be pushed into the syringe barrel.Medication was in the syringe.
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