Submit date: 08/22/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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The customer reports an issue with an umbilical vessel catheter (uvc).A small drop of blood was noted near the connection at end, a scant amount.Aiv asp when trying to aspirate blood from the uvc.Tried to flush, but the leak was noted near the connection (crack noted in uvc).There was no patient injury.
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A device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Sample received consisted in two uvc catheters, which came inside a generic plastic bag.One of the samples presents signs of use (remains of blood) and the other catheter returned closed.Under water test was performed and a leak below the strain relief could be identified in the used catheter.Magnified pictures were taken and in the sample a hole/tear was observed.Based on all gathered information, the most probable root cause for this event can be considered as costumer misuse.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.If information is provided in the future, a supplemental report will be issued.
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