Catalog Number 8065741081 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).
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Event Description
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A customer reported an unknown quantity of kinked cassette tubing noted before procedures.However, the reporter indicated that "the nurses rubbed the kink out and continued to use the product for procedures without any consequences or impact to the patients." additional information was requested from the reporter.Upon follow up the reporter indicated that patients identifiers, product samples, and dates of events were not recorded or saved.
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Manufacturer Narrative
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As the customer did not retain the finished goods lot number; a device history record and lot history could not be reviewed.Also, visual inspect or functional testing could not be conducted.The root cause of the customer's complaint could not be established.(b)(4).
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Search Alerts/Recalls
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