Model Number 21-7302-24 |
Device Problems
Partial Blockage (1065); Complete Blockage (1094); Obstruction of Flow (2423)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Operator of device is unknown.No information has been provided to date.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.
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Event Description
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It was reported had multiple disposable issues.The patient was unable to push liquid into the disposable.It occurred with multiple disposables when they tried to push liquid into them.No further information was known.
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Manufacturer Narrative
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Other text: patient identifiers, patient date of birth, event outcome and product lot number were provided.
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, this complaint will be reopened for further investigation.
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Search Alerts/Recalls
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