(b)(4).The customer returned one, partially opened cvc kit for analysis.The lidstock was opened at the bottom right corner of the tray.The tray was completely sealed in all other locations along the tray.Visual analysis revealed that the tray contained a large crack at the bottom-right corner of the tray.This crack creates a sterility breach in the kit.In addition to the damage, the lidstock was peeled back in the same subsequent area as the damage.It was noted that adhesive residue was observed along the lip of the tray around the opened area.This confirms that the seal between the tray and lidstock was completely intact before it was partially opened.The packaging facility was contacted as part of this complaint investigation.They indicated that all trays are 100% inspected according to manufacturing instructions for molding of trays.Also, all finished goods packaged are 100% inspected after sealing in accordance to manufacturing instructions.They also stated that it appears as if the tray was damaged after the packaging process occurred.Packaging r & d was also contacted as part of this complaint investigation.They indicated that as the lidstock was partially removed in the same area as the crack, it appears as if the damage likely occurred when the kit was being opened; however, as the customer does not mention when they observed the defect, it cannot be determined if this damage occurred before or after the tray was partially opened.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package is damaged".The report of a sterility breach was confirmed through complaint investigation of the returned sample.Visual analysis revealed a large crack in the tray.This crack would have created a breach in the seal.It was also noted that the listock was opened in the same area as the crack in the tray.Confirmation from the packaging facility and packaging r & d confirmed that the trays/kits are 100% inspected for this type of damage.Therefore, the damage likely occurred after the packaging process.Additionally, it cannot be determined if the crack in the tray occurred before or after the tray was partially opened.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
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