Model Number 11823 |
Device Problems
Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2022 |
Event Type
Injury
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Event Description
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Information was received by patient tracking reported a catheter revision.No further information is available at this time.
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Manufacturer Narrative
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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 not returned for additional evaluation and investigation.The cause of the alleged issue has not yet been confirmed.Pending follow-up from the physician's office.Internal complaint number: (b)(4).
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Event Description
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Additional communication with the representative covering this issue confirmed that the patient had experienced a lack of pain relief.A catheter dye study was performed and showed that the catheter was kinked.The device was revised and not returned.
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Manufacturer Narrative
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Device was 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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Search Alerts/Recalls
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