Model Number 714100 |
Device Problem
Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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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The customer reported that the patient noticed a broken balloon five days after the insertion of the probe.The probe has been replaced with a new one.Per additional information provided on july 13, 2022, the break was a clean tear, there were no fragmented pieces.
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Manufacturer Narrative
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Section h6 "type of investigation" corrected from 4101 (testing of device from same lot/batch returned from user) to 10 (testing of actual/suspected device).
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Manufacturer Narrative
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The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The device was manufactured on august 04, 2021.One decontaminated nutriport with lot 2120818664 was received at the manufacturing site for investigation.A visual inspection and functional test were performed, and the reported condition was confirmed.The balloon was inflated with water and left for a few minutes and a leak was observed.The affected component is product by a supplier.A supplier corrective action request (scar) has been issued to the supplier for further investigation.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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