MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8888411405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient's pd (peritoneal dialysis) catheter had a leakage and degradation at the shaft of tubing (it became thin and titanium adapter was detached and had a leakage.The nurse cut the degraded tubing shaft and returned it for evaluation).The catheter was not repaired and there was no leakage at the junction of the bifurcate.Tego was not utilized and there were no luer adapter issue.It was also stated that the patient was responsible for the device maintenance which it follow the general care instruction provide by the facility and there was no medical intervention done to the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information: g4, h3, h6 h3.Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.A visual inspection of the returned photo noted a segment of tubing.No leak could be seen from the photo.As no physical product was returned, functional testing could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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.
Additional Manufacturer Narrative
Additional information: b5, g4, h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photograph were returned for evaluation.It was reported that catheter shaft is leaking, cracked and broken.An associated device issue could not be confirmed.Visual inspection and testing found no potentially contributing factors, and the sample met all related specifications.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that products meet all medtronic quality specifications.The most likely root cause could not be identified because no problem was detected with 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.
Event or Problem Description
According to the reporter, the patient's pd (peritoneal dialysis) catheter had a leakage and degradation at the shaft of tubing (it became thin and the titanium adapter was detached and had a leakage.) the nurse cut the denatured tube shaft and used an extension tube to be connected with implanted parts to resolve the issue.The catheter was not repaired and there was no leakage at the junction of the bifurcate.Tego was not utilized and there were no luer adapter issue.It was also stated that the patient was responsible for the device maintenance which it follow the general care instruction provide by the facility and there was no medical intervention done to the patient.There was no reported patient injury.
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, the patient's pd (peritoneal dialysis) catheter had a leakage and degradation at the shaft of tubing (it became thin and titanium adapter was detached and had a leakage.The nurse cut the degraded tubing shaft and returned it for evaluation).The catheter was not repaired and there was no leakage at the junction of the bifurcate.Tego was not utilized and there were no luer adapter issue.It was also stated that the patient was responsible for the device maintenance which it follow the general care instruction provide by the facility and there was no medical intervention done to the patient.There was no reported patient injury.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9407787
• Report Number: 3009211636-2019-00258
• Device Sequence Number: 3999668
• Product Code: FJS
• UDI-Device Identifier: 10884521054974
• UDI-Public: 10884521054974
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8888411405
• Device Catalogue Number: 8888411405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 05/26/2020; 06/10/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/21/2020; 05/27/2020; 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1