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Model Number 8884773006 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Information (3190)
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Event Date 12/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.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 after using for a few minutes, the tube started to leak.
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Manufacturer Narrative
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The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One (1) used sample was received at the manufacturing site for evaluation.During visual and functional inspection it was noticed that the silicone tubing that is assembled/connected to the one-way mistic was cut preventing the food to have free flow through the sample.The mistic pvc piece was inspected and no sharp edges were detected nor was the silicone tubing found to be weak on any other point therefore t he root cause could not be related to manufacturing.This complaint will be closed with no further action and will be used for tracking and trending purposes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Search Alerts/Recalls
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