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

Model Number 8888145041P

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

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 dialysis treatment, a hair crack was observed on the patient's device (venous adapter).They had to use a repair kit to resolve the issue and there was no blood loss.There were no other products utilized on the device and no other defects/damages found on the product where the cracks was observed.It was also stated that they tighten the adapters by hands and octenisept was used as cleaning agent to clean the adapters.The insertion site was not treated prior to product placement and there was no any patient symptoms or complication associated with this event.There was no medical intervention done to the patient and tego was not utilized.There was no reported patient injury.

Manufacturer Narrative

Additional information: g4, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and photographs were returned for evaluation.No visible cracks or damage was noted in the pictures.Visual inspection of the returned product found no visible cracks on the adaptors or clamps.The sealing caps were still sealed in their packaging.It was reported that luer adapter was leaking, cracked and broken.An associated device issue could not be confirmed from the samples provided.The most likely root cause could not be identified, because no related device-issue was identified.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 10062006
• MDR Text Key: 193682045
• Report Number: 3009211636-2020-00100
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 20884521158044
• UDI-Public: 20884521158044
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: 8888145041P
• Device Catalogue Number: 8888145041P
• Device Lot Number: 1707500189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 68