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

Model Number 8888145014

Device Problems Break (1069); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

According to the reporter, during normal use, the catheter that was inserted into the patient had a small pin-prick-type hole and a leak at the luer adapter.No crack was observed in the luer adapter.The insertion site was not treated prior to product placement.The catheter was not repaired.The patient was rewired the next day once the hole was noted.There was no reported patient injury.

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 Description

According to the reporter, a small pin-prick-type hole was noted at the venous extension tube.The catheter was flushed after insertion and used for the x1 run, and nothing abnormal was noted.Flushed day pinhole noted, patient hooked up to hd (hemodialysis).Blood was noted on the dressing, but it was a newly inserted tcc (tunneled cuffed catheter), so it was not unexpected if it was observed prior to hd treatment.The catheter had been in place for two days.The policy was to move the clamps (q-run).No crack was observed in the luer adapter.The insertion site was not treated prior to product placement.The catheter was not repaired.There was no luer adapter issue.No other products were being utilized with the device.Either chlorhexidine wipes or alcohol wipes were cleaning agents used on the device and were the cleaning agents typically utilized to clean the adapters.The standard was to let the cleaning agents dry thoroughly.No ointment was applied to the area.Tego was utilized.The patient was rewired urgently with the same brand (23 cm) and a different lot the next day once the hole was noted as an intervention for the patient due to the event, and the treatment was completed.There was very minimal (a few drips) blood loss.A blood transfusion was not required.The patient had no air embolism due to the event.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, d6a, d6b, e1 (first name, last name, fax number, phone number), e2, e3, g3, h3, h6 (fdd) 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 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18505249
• MDR Text Key: 333218825
• Report Number: 3009211636-2024-00024
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: 10884521013148
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2227200235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1