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

Model Number	8888541055P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, before the treatment, it was stated that when changing the dressing of the catheter, the nursing team noticed that the hub and the extensions were disconnected.Nothing unusual observed aside from the reported issue.The catheter was repaired.Chloraprep was the cleaning agent used on the device.Cleaning agent(s) is allowed to dry thoroughly prior to dressing and prior to applying ointment to the area.Tego was not utilized.No other products being utilized with the device.There was a blood leak due to the detachment and had a blood loss of few ml but no blood transfusion was required.No other defects/damages found on the product where the leak was observed.No other medical intervention/treatment due to the event.It was said that the catheter had been clamped and a new hub and extensions were connected (catheter was not fully explanted but repaired).Treatment was completed after the repair.There was no reported patient injury.
Event or Problem Description
According to the reporter, before the treatment, it was stated that when changing the dressing of the catheter, the nursing team noticed that the hub and the extensions were disconnected.Nothing unusual observed aside from the reported issue.The catheter was repaired.Chloraprep was the cleaning agent used on the device.Cleaning agent(s) is allowed to dry thoroughly prior to dressing and prior to applying ointment to the area.The insertion site was treated with chloraprep prior to product placement.Tego was not utilized.No other products being utilized with the device.There was a blood leak due to the detachment and had a blood loss of few ml but no blood transfusion was required.No other defects/damages found on the product where the leak was observed.No other medical intervention/treatment due to the event.It was said that the catheter had been clamped and a new hub and extensions were connected (catheter was not fully explanted but repaired).Treatment was completed after the repair.There was no reported patient injury.
Additional 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.
Additional Manufacturer Narrative
H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that half of a catheter including the venous and arterial lumen were attached at the y-hub.The y-hub was disconnected from the cannula.It was reported that the catheter shaft disconnects from the hub.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.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
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10752301
• Report Number: 3009211636-2020-00264
• Device Sequence Number: 3195785
• Product Code: MSD
• UDI-Device Identifier: 10884521158542
• UDI-Public: 10884521158542
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 8888541055P
• Device Catalogue Number: 8888541055P
• Device Lot Number: 1926100249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 01/26/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/20/2020; 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1