Qn#(b)(4).The customer did not return a complaint sample; however, they supplied two photos showing a lidstock and a vessel catheter.The image shows the catheter next to a ruler.The catheter appears to be the same catheter that is packaged within the finished kit, but it cannot be determined without the actual sample to evaluate.The catheter product drawing was reviewed.The catheter shown in the customer image appears to meet the dimensional specifications of 3 1/16"-3 9/16"; however, this cannot be officially confirmed without the sample to evaluate.Engineering was contacted as part of this complaint investigation.They indicated that the product is labeled by the maximum length based on tolerance.Labeling for max length instead of the last cm mark was likely the practice at the time this legacy product was created.A device history record review was performed and no relevant findings were identified.The report of an incorrect catheter was not confirmed through examination of the customer supplied images.The image shows a vessel catheter next to a ruler.The catheter appears to meet the dimensional requirements indicated in the catheter product drawing; however, this cannot be officially confirmed without the actual sample to evaluate.A device history record review was performed, and no relevant findings were identified.Engineering was contacted as part of this complaint investigation.They indicated that the product is labeled by the maximum length based on tolerance.Labeling for max length instead of the last cm mark was likely the practice at the time this legacy product was created.Based on the comments from engineering and the customer provided image, the probable cause for this complaint could not be determined.Teleflex will continue to monitor and trend for reports of this nature.
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