It was reported that an unspecified number of blood/solution anaesthesia/pca infusion sets had connection cracks which caused leaking at the connection site.This was further described by the customer as when the set was used as an intravenous (iv) line there were no issues, however, when the set was connected to a pca (patient controlled analgesia) device, ¿they were getting blood syphoning up the line/the line was leaking at the pca connection or the pca¿.This was identified during use for patient infusions.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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H10: a batch review was conducted, and there were no deviations found related to this reported condition, during the manufacture of this lot.The actual device was not received for evaluation.Therefore, a device analysis could not be completed.An unspecified quantity of retention samples were visually inspected, and no obvious issues or damages were detected.These samples were also gravity tested.And under water leak tested, with no leaks observed.The retention samples were conforming, as per product specification.The reported condition was not verified, in the retention sample evaluation.Should additional relevant information become available, a supplemental report will be submitted.
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