COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813793009 |
Device Problems
Product Quality Problem (1506); Insufficient Flow or Under Infusion (2182); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/05/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, they received feedback from the hospital that during the process of passing through the guide wire, the catheter had completely failed to pass through the guide wire, became stuck and the guide wire was bent.Even if it was barely successfully implanted, the flow performance during subsequent use was poor and could not meet treatment needs.After repeated communication, the customer still said that the difficulty of using this product brought great inconvenience and risk to the surgery and the use effect after implantation was also poor.The hospital also believed that the product was defective in manufacturing and the probability of problems is extremely high and so they refused to continue using this model of product and required the return of all 11.5fr (french) acute catheter products.The catheter was not repaired and there was no cleaning agent used on the device.Tego was not utilized, and the insertion site was not treated prior to product placement.There was no reported patient outcome.
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Manufacturer Narrative
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D10 concomitant product: 8813793009 11.5fr 19.5cm mahurkar kit (lot#: 2001400106) 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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Additional information: e1(last name, facility name, street 1, city, region and phone number), e3, g2, g3, h3, h6 correction: d10 (removed concomitant devices) new information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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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