Pending device return for analysis.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 and non-conformances, issues or capas associated with us catheter kit function.Internal complaint number: (b)(4).
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Corrected information: d9, h3, h6.Device was returned for additional evaluation and investigation.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.Additional physical investigation was performed on the device, confirming the alleged issue.Visual analysis concluded a possible occlusion at the distal end.The catheter was observed under magnification, and the occlusion was confirmed.Engineering cannot determine what the material is that is causing the occlusion.Internal complaint meeting: (b)(4).
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