Model Number 11823 |
Device Problem
Obstruction of Flow (2423)
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Patient Problems
Diarrhea (1811); Nausea (1970); Chills (2191); Inadequate Pain Relief (2388); Shaking/Tremors (2515)
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Event Date 12/20/2021 |
Event Type
Injury
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Manufacturer Narrative
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Pending additional follow up information.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.Internal complaint number: (b)(4).
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Event Description
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Information was received that reported a catheter replacement due to lack of flow through the catheter.The patient had complained of withdrawal symptoms, specifically shaking, chills, nausea and diarrhea in addition to increased pain.It was stated that a dye study was performed.During the replacement surgery, the physician could not detect any areas of abnormality on the catheter itself but there was no leaking of csf after catheter removal.The cause of the issue was determined to be unknown, and the replaced catheter was discarded.
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Manufacturer Narrative
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Device was discarded and not returned.Although the exact cause could not be established, the instructions for use for the device addresses risks associated with the catheter that may be related to the alleged lack of flow through the catheter.Internal complaint number: (b)(4).
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Event Description
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Additional information was provided stating that the dye study revealed that there was clearly an abnormality with the catheter because the physician could not aspirate any clear fluid despite unquestionable access to the catheter access port.
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Search Alerts/Recalls
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