(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 175460.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.With no sample analysis a probable root cause could not be offered.
|
It was reported that 12 10 ml bd posiflush¿ normal saline syringes experienced difficult plunger movement.The following information was provided by the initial reporter: the nurse in the ct room of the user facility performed an intravenous indwelling needle puncture for a patient undergoing enhanced ct, when evaluating whether the pipeline is unobstructed, the product was used to conduct a catheter evaluation.When the infusion connector was connected, the infusion was blocked.After the connector was removed, the plunger rod was pushed to find a clear resistance and could not be pushed.12 similar incidents occurred that day.
|