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

Model Number 8888145016

Device Problem Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, it was stated that the red luer adapter was broken/cracked, but no air came into the catheter.Nothing unusual was observed prior to use.The catheter had no leak.Octenisept was the cleaning agent used on the device and to the adapters.Cleaning agents were not allowed to dry thoroughly prior to applying ointment(s) to the area.Tego was utilized.No instrument was used to loosen or tighten the device.There was no blood loss, and no blood transfusion was required.No medical intervention/treatment due to the event.The catheter was not repaired and said to be still in use.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, d8, g3, h6 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 Description

According to the reporter, during use (after the dialysis), it was stated that the red luer adapter was noted to be broken/cracked but no air came into the catheter.Nothing unusual observed prior to use.The catheter had no leak.Octenisept was the cleaning agent used on the device and to the adapters.Cleaning agents were not allowed to dry thoroughly prior to applying ointment(s) to the area.Tego was utilized.Only hands were used to loosen or tighten the device (no instrument used).There was no blood loss and no blood transfusion was required.No medical intervention/treatment due to the event.The catheter was not repaired and said to be still in use.Nothing was done to resolve the issue as the dialysis functioned without air bubble.There was no reported patient injury.

Manufacturer Narrative

H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the venous and arterial luer adaptors were damaged at the connection site.It was reported that the luer adapter was broken.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10822817
• MDR Text Key: 217427388
• Report Number: 3009211636-2020-00279
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521013176
• UDI-Public: 20884521013176
• Combination Product (y/n): N
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2021
• Device Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 1611800136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 55