Model Number 765559 |
Device Problem
Complete Blockage (1094)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Submit date: (b)(6) 2017.A good faith effort will be made to obtain the applicable information relevant to the report.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 reported that during the second feeding, the flexible tube always gets clogged in the flexible tubing near the end that connects to the joey pump and they are unable to unclog it.This has occurred numerous times with this patient.No patient injury.
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Manufacturer Narrative
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Patient codes, was corrected.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 reported that during the second feeding, the flexible tube always gets clogged in the flexible tubing near the end that connects to the joey pump and they are unable to unclog it.This has occurred numerous times with this patient.No patient injury.
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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.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the complaint 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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Search Alerts/Recalls
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