(b)(4).The customer provided one photo for analysis.The complaint of an extension line stretched/ballooned was confirmed through visual inspection of the photo.The photo shows a deformed medial extension line, near where the extension line clamp was placed.The customer returned one, 3-l pressure-injectable cvc for evaluation.Signs-of-use were observed on the catheter body and inside the extension lines.The catheter was returned with the medial extension line slide clamp in the open position.Visual inspection of the catheter revealed the medial extension line was stretched/ballooned partway down the extrusion.The damage appears consistent with unintentional over pressurization of the extension line during use.The deformation in the medial extension line was located 0-25mm from the luer hub.The outer diameter of the medial extension line in a non-deformed area measured 0.08549" which is within the specifications of 0.084"-0.088" per product drawing.The inner diameter of the medial extension line could not be accurately measured due to the damage.Functional inspection of the catheter was performed per the instructions-for-use (ifu) provided with the kit which states, "ensure patency of each lumen of catheter prior to pressure injection to minimize the risk of catheter failure and/or patient complications." the catheter lumens were flushed using a lab inventory 10ml syringe.All lumens flushed as expected, with no leaks or blockages observed.The instructions-for-use (ifu) provided with the kit warns the user , "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.Precaution: pressure limit settings on injector equipment may not prevent over pressurizing an occluded or partially occluded catheter." the customer report of a stretched/ballooned extension line was confirmed through complaint investigation of the complaint sample.Visual inspection revealed the medial extension line was deformed partially down the extrusion.The damage appeared consistent with unintentional over pressurization of the extension line during use.The instructions-for-use (ifu) provided with the kit warns the user, "warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure".Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
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