MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145048
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the catheter's luer connectors/adapters had leaked three weeks after the catheter was placed.The catheter was not repaired and there was no crack observed on the luer adapter.Clorhexidine was used as a cleaning agent on the device and the insertion site was not treated prior to product placement.It was mentioned that it was not possible to do hemodialysis treatment and the patient entered the operating room again for catheter replacement.The event also led to or extend patient hospitalization for 3 days.
Additional Manufacturer Narrative
H3 evaluation summary: post market vigilance (pmv) led a video graphic evaluation of one device.The visual inspection of the returned video's noted: the first video depicts the surgeon inject a clear fluid into the blue luer adapter.There is a leak at the extension tube.The second video depicts the surgeon injecting a clear fluid into the red luer adapter.The clamp at the extension tube is fully clamped and there is a leak at the threaded adapter where the syringe is attached.Without the physical device functional evaluation is precluded.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.If information is provided in the future, a supplemental report will be issued.
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.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, during hemodialysis treatment, the catheter's luer connectors/adapters (both red and blue) had leaked three weeks after the catheter was placed.The catheter was not repaired and there was no crack observed on the luer adapter."chlorhexidine" was used as a cleaning agent on the device and the insertion site was not treated prior to product placement.There were no other products being utilized with the device and the doctor felt something was not right prior to the use of the device but it was still used.Flushing was done and there was no leakage or only a drop.There was no blood loss and blood transfusion was not required.It was mentioned that it was not possible to do hemodialysis treatment and the patient entered the operating room again for catheter replacement (re-intervention was necessary with hospitalization).There was no harm to the patient but the event also led to or extend patient hospitalization for 3 days.It was stated that the patient is now okay.
Additional Manufacturer Narrative
Additional information: d4(udi#), d8, g3 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.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9573224
• Report Number: 3009211636-2020-00016
• Device Sequence Number: 3244531
• Product Code: MSD
• UDI-Device Identifier: 20884521013275
• UDI-Public: 20884521013275
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/16/2022
• Device Model Number: 8888145048
• Device Catalogue Number: 8888145048
• Device Lot Number: 1904600084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 01/23/2020; 02/17/2020; 01/07/2021
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 02/05/2020; 03/10/2020; 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention