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Model Number BB10R29R9 |
Device Problems
Disconnection (1171); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product analysis: visual inspection showed that the luer fitting was broken off one end of the tubing.The reason for return was confirmed.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 this custom tubing pack, the customer reported that a pressure line that was supposed to be pre-connected to a 1/4 x 1/4 luer connector was broken at the connection site.The male end remained attached, but the tubing was separated.The tubing was replaced with standard pressure tubing and used without incident.There was no patient involvement so no adverse patient effects occurred. additional information was received stating that there was no visible damage to the packaging or surrounding items.
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Manufacturer Narrative
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Correction b5: additional information received stated that the inlet port of the fusion oxygenator was also broken.Correction h6: fdd/annex a code a0406 added.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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Manufacturer Narrative
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Medtronic received additional information that the oxygenator ports were completely broken off.Complaint is confirmed for broken pressure line reported.Based on the investigation results no root causes were confirmed that lead to the origination of the failure mode of broken pressure line.Supplier and current production personnel and supervisors were notified of the product event reported.After evaluation the cause of this complaint could not be determined.Complaint is confirmed for broken inlet port in the fusion oxygenator.Root cause investigation is still in progress.There were no patient/clinical safety issues reported.Medtronic will continue to monitor for future occurrences and trends per trend analysis procedure.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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