The international customer reported that, while accessing the lumen of the triple lumen silicone central venous/hyperalimentation catheter, pinholes were discovered in the lumen.Ultimately the product issue necessitated the exchanging of the line.The complaint device was originally implanted 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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Investigation ¿ evaluation: a review of complaint history, device history record, documentation, drawing, instructions for use, quality control, and specifications was completed during this investigation.No complaint device has been returned for investigation.However, a documentation review was completed.A review of the device history record found no other non-conformances associated with the complaint device lot number (ns7981843).Additionally, a review of the manufacturer's complaint database found one other complaint associated with the complaint device lot number (ns7981843).Clinical assessment: there is no information regarding the placement location of the device.Per the ifu, ¿placement of this catheter into the subclavian vein may result in compression of the catheter by the clavicle and first rib.Excessive compression may result in catheter damage, including rupture or catheter embolus.¿ there is no information regarding the monitoring of the device.Per the ifu, ¿extreme caution must be used in placement and monitoring.¿ there is no information regarding power injecting or the syringe size used during flushing of the device prior to use if heparin locked as recommended by the ifu.Per the ifu, ¿do not power inject contrast medium through the catheter.Catheter rupture may result.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.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 a definitive root cause cannot be established or reported at this time.This failure mode has been escalated per internal processes.
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