The suspect device has been returned for evaluation.The device was examined visually, the break found in the tubing appeared to be rigid ,the catheter was not cut.The freka schlauchkelemme weiss clamp is not qualified to be used on the pd catheter and not ifu recommended.The ifu states "if necessary, use clip included in kit to clamp the catheter to control the flow of saline".The catheter had also been in the patient for over three years.The age of the catheter and the clamp most likely caused some wear/damage to the integrity of the tubing and then broke when under pressure.The customer's complaint is confirmed.The root cause is attributed to using an unqualified clamp on the tubing and the age of the catheter.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.
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