(b)(4).The customer returned one arterial catheter.Signs of use were identified in the form of biological material (dried blood) and sutures on the juncture hub.A kink was identified adjacent to the juncture hub.The catheter body measured 84mm in length, which is within the range of 82 - 86mm specified by the product drawing.A lab inventory syringe was used to inject water into the catheter, but the water did not pass through the distal tip.A lab inventory guidewire was passed through the catheter and dried blood exited the distal tip.Once the obstruction was cleared the catheter aspirated without issue.The lot number was not reported; therefore a device history record review was performed based on a potential lot number from the sales history of the customer.No relevant findings were identified.The instructions-for-use (ifu) that are packaged with this kit provides information on the care and maintenance of an inserted catheter.The customer reported issue of the catheter being obstructed was confirmed during the complaint investigation.The customer returned one used arterial catheter for evaluation.Dimensional inspections was performed and no issues were identified.During initial functional inspection and obstruction was identified, preventing water from passing through the catheter.The obstruction was cleared and identified to be dried blood.After the obstruction was cleared the catheter functioned as intended.A device history record review was performed based on sales history and no relevant findings were identified.Based on the information and sample provided, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend or reports of this nature.
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