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Model Number 31001 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Visual inspection of the 2 opened devices shows minimal tyvek adhesive transfer on the seam, reason for return was confirmed.Complaint confirmed for in complete sealing of the device pouch.This occurrence is the result of an issue at the supplier of the tyvek used to manufacture the device.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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Event Description
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Medtronic received information that prior to use of a dlp i.M.A.Cannula, the customer reported that the sterile packaging was not s ealed.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the device was located in the seal but it was not fully sealed all the way.A quantity of seven devices is involved with this complaint.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received information that prior to use of a dlp i.M.A.Cannula, the customer reported that the sterile packaging was not s ealed.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the device was located in the seal but it was not fully sealed all the way.
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Search Alerts/Recalls
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