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

Model Number 8888145044CP

Device Problem Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/14/2019

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 hemodialysis treatment, micro bubbles were seen in the dialysis tube, the nurse discovered a hole in the venous extension tube which was leaking.It was also reported that they reversed the line using the arterial extension side but treatment was terminated immediately.They removed the leaking part and inserted a tube to repair but it did not work.The patient was given acute double running central venous catheters so hemodialysis could be implemented.There was no reported patient outcome.

Manufacturer Narrative

Additional information: a2 (date of birth), a4, b5, d6, g4, 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 hemodialysis treatment, micro bubbles were seen in the dialysis tube, the nurse discovered a hole in the venous extension tube which was leaking.The catheter lumens were flushed prior to use and the clamps were noted to be moved periodically.There was nothing unusual observed on the device prior to use and there were no other products being utilized together with the device, tego was not utilized, and there was no luer adapter issue.The insertion site was treated with chlorhexidine and the catheter was cleaned with 70% alcohol.It was also reported that they reversed the line using the arterial extension side but treatment was terminated immediately.They removed the leaking part and inserted a tube to repair but it did not work.The patient was given acute double running central venous catheters so hemodialysis could be implemented but treatment was not completed.There was eventual blood loss of about 10 ml but there was no need for blood transfusion.The device was again replaced with a new catheter and treatment was completed.There was no other intervention done as a result of the issue aside from the replacement of the device.There was no reported patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 9525870
• MDR Text Key: 194118219
• Report Number: 3009211636-2019-00288
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158085
• UDI-Public: 10884521158085
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2022
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Device Lot Number: 1910200095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 93