(b)(4).The customer returned one 2-l cvc for analysis.Signs of use in the form of biological material was observed on the catheter body and inside the extension lines.The catheter appeared intentionally cut.Visual analysis revealed that the distal extension line was stretched/ballooned.The stretching started adjacent to the distal luer hub.The appearance of the damage is consistent with unintentional over pressurization of the extension line during use.The stretching on the distal extension line measured 1mm-9mm from the distal luer hub.The catheter length from the juncture hub to the severed end measured 2 7/8", which is not within the specifications of 4 13/16"-5 3/16" per product drawing.This indicates that at least 1.9375" of the catheter were severed and not returned for analysis.The distal extension line outer diameter in an area not affected by stretching measured 0.08558", which is within the specifications of 0.084"-0.088" per product drawing.The distal extension line inner diameter measured 0.057", which is within the specifications of 0.055"-0.059" per product drawing.A lab inventory syringe filled with water was attached to the distal extension and flushed.Water was observed exiting the distal end as intended.No leaks or blockages were observed.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." no obstructions were observed when flushing the proximal extension line.A manual tug test confirmed both extension lines were fully secured onto their respective luer hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with the kit informs the user, "using catheters not indicated for pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." and also cautions the user "warning: open slide clamp prior to infusion through lumen to reduce risk ofdamage to extension line from excessive pressure.Ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture." the report of a stretched/ballooned extension line was confirmed through complaint investigation.Visual analysis revealed that the distal extension line was stretched/ballooned.The catheter flushed as expected, the catheter met all relevant dimensional requirements, and a device history record review was performed based on a potential lot with no relevant findings to suggest a manufacturing related cause.Based on the customer report and the appearance of the damage to the catheter, unintentional use error (overpressure) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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