Model Number 762055 |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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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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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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It was reported to covidien on (b)(6) 2017 that a customer had an issue with an enteral feeding pump set.The customer reports the bags are leaking and there are holes in the bags.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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