The international customer reported that, while accessing the lumen of the triple lumen silicone central venous/hyperalimentation catheter, several pinholes were noted in the blue lumen while saline was being infused to check the patency of the device.The tubing was then clamped with the blue clamps as well as the present lumen clamp the staff continued and processed with photopheresis using the red lumen in single needle mode, but ultimately the product issue necessitated the exchanging of the line.The complaint device was originally implanted on (b)(6) 2017 and the leak was discovered on (b)(6) 2017.Additional information has been requested from the customer, but none has yet been provided.The complaint product is reportedly unavailable for return and evaluation.
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Pma/510(k): preamendment.Investigation ¿ evaluation a review of the complaint history, device history record, documentation, specifications, and quality control data was conducted during the investigation.The complaint device was not returned therefore, a physical examination of the device used in this case could not be performed.However, a document review was performed.A review of the device history record found no other non-conformances associated with the complaint device lot number (ns7775311).Additionally, a review of the manufacturer's complaint database found one other complaint associated with the complaint device lot number (ns7775311).Clinical assessment: there is no information regarding the placement location of the device.There is no information regarding the syringe size used during flushing of the device prior to use if heparin locked as recommended by the ifu.Per the ifu, ¿use of a 10ml or larger syringe will reduce the risk of catheter rupture.¿ there is no information regarding securing of the device to prevent pulling or tension.There is no information regarding patient environment (e.G.Iv lines tangled on bed frame/bed rails/bedding, patient positioning, patient pulling on iv lines) that may have contributed to this event.It is not certain that the single needle system contributed to the line rupture and there is no information regarding the monitoring of the pressures used.The device will not be returned of evaluation.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.At this time, the clinical assessment cannot eliminate any possible causes for this event such as this particular medical procedure, monitoring, user technique, device handling, device failure, or manufacturing related causes based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.This complaint is confirmed based on the customer's testimony.Based on the provided information, the root cause of this event is undeterminable.This failure mode has been escalated per internal processes.
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