Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Pma/510(k)#: k980580(syringe) k951254(needle).Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.
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Material no.: 305903, batch no.: unknown.It was reported that during use of the bd safetyglide¿ insulin syringe with attached needle the safety mechanism is difficult to engage.This occurred on 4 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter: safety mechanism is difficult to engage requiring people to report near misses (when engaging the safety, the needle can easily come apart from the syringe).
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