(b)(4).The customer returned one, separated distal luer hub (brown hub) for analysis.The rest of the catheter was not returned.No definite signs of use were observed.Visual analysis revealed that the distal luer hub was separated from the catheter.Microscopic examination confirmed the damage and revealed that a portion of the extension line was still molded within the luer hub.Visual analysis could not be performed on the rest of the catheter as it was not returned for analysis.Functional and dimensional inspection could not be performed as only the separated luer hub was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.".The report of a separated luer hub was confirmed through complaint investigation.Visual analysis revealed that the distal luer hub had separated from the catheter.Additionally, a portion of the extension line was still inside the separated hub.Despite this, a complete visual/dimensional/functional analysis could not be performed on the rest of the catheter as it was not returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the entire device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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