A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit.Device was discarded and not returned for additional evaluation and investigation.Agent stated that the cause of the catheter fraying was unknown.Per the instructions for use of the device, catheter tearing is a known possible risk of use of the device.Internal complaint number: (b)(4).
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Patient tracking received a tracking form alleging a catheter replacement.Per follow-up, agent reported, "the existing catheter was frayed, doctor replaced.Patient is fine now.The patients symptoms increased which is why they knew to assess if the catheter was frayed and it was.Patient is doing great now.All the catheter that was old was disposed of.Nothing will be sent in." additional follow up communication confirmed that the cause of the catheter fraying was unknown.
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