Model Number 8884711253 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Submit date: 1/29/2018.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer states that the enteral access ng tube was kinked.
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Manufacturer Narrative
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One decontaminated sample was received for evaluation.The device history record was reviewed and indicated that the product was release accomplishing all quality standards.After performing a visual inspection, kinking was observed in the tubing.The reported issue was confirmed.The most likely root cause indicates that this issue could occur due inadequate use of the procedure if the instructions of use are not followed.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.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 issue 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.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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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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Search Alerts/Recalls
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