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

Model Number 8888145044P

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

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 treatment, blood leak was noted coming from the distal junction of the venous branch.It was stated that there was a break at this place.Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism.The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention.There was no reported patient injury.

Manufacturer Narrative

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

Event Description

According to the reporter, during treatment, blood leak was noted coming from the distal junction of the venous branch.It was stated that tego adapter was used to tighten the adapters and the cleaning agent used was chlorhexidine 2% alcohol 70 %.It was stated that there was a break at this place.Treatment was not initiated as there was a risk of air entering the leak and pulmonary embolism.The venous branch was repaired with the repair kit and a dose of antibiotics was given as an intervention.It was also stated that it was a luer adapter issue as the small leak came from under the white rubber part.There was no significant blood loss due to the leak.There was no reported patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that only the blue port venous lumen was received.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8293615
• MDR Text Key: 134742744
• Report Number: 3009211636-2019-00017
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158092
• UDI-Public: 10884521158092
• 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,Followup
• Report Date: 04/15/2019

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: 04/24/2019
• Device Model Number: 8888145044P
• Device Catalogue Number: 8888145044P
• Device Lot Number: 1613900109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 02/11/2019; 03/26/2019
• Supplement Dates FDA Received: 03/06/2019; 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1