A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.Device was discarded and not returned for additional evaluation and investigation.Per the instructions for use of the device, catheter kinking is a known possible risk of use of the device.Internal complaint number: (b)(4).
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Clinical specialist (cs) reported that a dye study was performed that showed that the patient's catheter was kinked.During follow-up, it was confirmed that the catheter was replaced and discarded.Additionally, during follow-up, it was determined that the patient's pump was replaced as well.The patient's pump replacement was captured through mfr 3010079947-2021-00312.
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