No product samples were returned for investigation, however, two photographs were returned showing a (b)(4) bag spike inserted into a drug bag.There was a towel under the spike/bag assembly and wetness was confirmed under a large portion of the area under the (b)(4) bag spike inserted into a drug bag.It was not possible to determine from the photo the origination of the leakage.The device history review was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The probable cause of the leakage cannot be determined from the photo and information provided.
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The event involved a clave¿ connector iv bag access device that leaked cyclophosphamide.It was reported that during infusion, a solution container of cyclophosphamide was found to be leaking from the clave attachment when it was hung.There was no leak observed when unpacking the container and there was no observable damage to the clave attachment.The patient was sitting, waiting for treatment.There was patient involvement, no skin contact with the cytotoxic solution by the patient or nursing staff, no report of patient harm or injury or medical intervention as a result of this event, however one of the nurses reported having a headache after the product leaked.The headache was temporary and resolved after the container was discarded.
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